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77 rows where docket_id = "FDA-2014-N-1210" sorted by posted_date descending
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| id | agency_id | docket_id | title | document_type | subtype | posted_date ▲ | posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FDA-2014-N-1210-3494 | FDA | None FDA-2014-N-1210 | Reference 58-Brown E.D. et al. Efficacy of continuation-maintenance electroconvulsive therapy for the prevention of recurrence of a major depressi RE: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-06T05:00:00Z | 2019 | 3 | 2019-03-06T15:33:14Z | 0 | 0 | 0900006483ac3808 | |||
| FDA-2014-N-1210-3493 | FDA | None FDA-2014-N-1210 | Reference 23-Shelef A. et al. Acute electroconvulsive therapy followed by maintenance electroconvulsive therapy decreases hospital re-admission ra RE: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-06T05:00:00Z | 2019 | 3 | 2019-03-06T15:33:05Z | 0 | 0 | 0900006483ac3807 | |||
| FDA-2014-N-1210-3449 | FDA | None FDA-2014-N-1210 | Reference 18-Luchini, F., et al., Electroconvulsive therapy in catatonic patients- Efficacy and predictors of response Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:59:45Z | 0 | 0 | 0900006483876153 | |||
| FDA-2014-N-1210-3434 | FDA | None FDA-2014-N-1210 | Reference 2-Reclassification of Daily Wear Spherical Contact Lenses Consisting of Rigid Gas Permeable Plastic Materials; Withdrawal of Proposed Rule FR-1983-12-23 Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:57:24Z | 0 | 0 | 0900006483875dfa | |||
| FDA-2014-N-1210-3436 | FDA | None FDA-2014-N-1210 | Reference 4 - FDA Executive Summary, Prepared for the January 27-28, 2011 meeting of the Neurological Devices Panel, Meeting to Discuss the Classification Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:57:41Z | 0 | 0 | 0900006483875dfc | |||
| FDA-2014-N-1210-3477 | FDA | None FDA-2014-N-1210 | Reference 47-Petrides, G., et al., Electroconvulsive therapy augmentation in clozapine-resistant schizophrenia- a prospective, randomized study Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:03:49Z | 0 | 0 | 0900006483875ea0 | |||
| FDA-2014-N-1210-3478 | FDA | None FDA-2014-N-1210 | Reference 48-Lehman, A.F., et al., Practice guideline for the treatment of patients with schizophrenia, second edition Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:03:58Z | 0 | 0 | 0900006483875ea1 | |||
| FDA-2014-N-1210-3481 | FDA | None FDA-2014-N-1210 | Reference 51-Small, J.G., et al., Electroconvulsive treatment compared with lithium in the management of manic states Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:04:24Z | 0 | 0 | 0900006483875ef1 | |||
| FDA-2014-N-1210-3459 | FDA | None FDA-2014-N-1210 | Reference 29-Puffer, C.C., et al., A 20 Year Practice Review of Electroconvulsive Therapy for Adolescents Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:01:03Z | 0 | 0 | 0900006483876176 | |||
| FDA-2014-N-1210-3463 | FDA | None FDA-2014-N-1210 | Reference 33-Consoli, A., et al., Electroconvulsive therapy in adolescents with the catatonia syndrome- efficacy and ethics Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:01:38Z | 0 | 0 | 090000648387617b | |||
| FDA-2014-N-1210-3455 | FDA | None FDA-2014-N-1210 | Reference 25-Unal, A., et al., Effective treatment of catatonia by combination of benzodiazepine and electroconvulsive therapy Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:00:31Z | 0 | 0 | 0900006483875e58 | |||
| FDA-2014-N-1210-3454 | FDA | None FDA-2014-N-1210 | Reference 24-Sienaert, P., et al., A clinical review of the treatment of catatonia Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:00:23Z | 0 | 0 | 0900006483875e56 | |||
| FDA-2014-N-1210-3437 | FDA | None FDA-2014-N-1210 | Reference 5-Fernie, G., et al., Detecting objective and subjective cognitive effects of electroconvulsive therapy- intensity, duration and test utility in a large clinical sample Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:57:53Z | 0 | 0 | 0900006483875dfd | |||
| FDA-2014-N-1210-3489 | FDA | None FDA-2014-N-1210 | Reference 60-Tor, P.C., et al., A Systematic Review and Meta-Analysis of Brief Versus Ultrabrief Right Unilateral Electroconvulsive Therapy for Depression Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:05:34Z | 0 | 0 | 09000064838a4653 | |||
| FDA-2014-N-1210-3458 | FDA | None FDA-2014-N-1210 | Reference 28-Lima, N.N., et al., Electroconvulsive therapy use in adolescents- a systematic review Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:00:53Z | 0 | 0 | 0900006483876175 | |||
| FDA-2014-N-1210-3465 | FDA | None FDA-2014-N-1210 | Reference 35-Walter, G. and J.M. Rey, An epidemiological study of the use of ECT in adolescents Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:01:53Z | 0 | 0 | 090000648387617d | |||
| FDA-2014-N-1210-3439 | FDA | None FDA-2014-N-1210 | Reference 7-Maric, N.P., et al., The acute and medium-term effects of treatment with electroconvulsive therapy on memory in patients with major depressive disorder Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:58:08Z | 0 | 0 | 0900006483875e0f | |||
| FDA-2014-N-1210-3442 | FDA | None FDA-2014-N-1210 | Reference 10-Ghaziuddin, N., D. Laughrin, and B. Giordani, Cognitive side effects of electroconvulsive therapy in adolescents Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:58:38Z | 0 | 0 | 0900006483875e12 | |||
| FDA-2014-N-1210-3467 | FDA | None FDA-2014-N-1210 | Reference 37-Strober, M., et al., Effects of electroconvulsive therapy in adolescents with severe endogenous depression resistant to pharmacotherapy Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:02:26Z | 0 | 0 | 0900006483875e81 | |||
| FDA-2014-N-1210-3486 | FDA | None FDA-2014-N-1210 | Reference 56-FDA, MedWatch- The FDA Safety Information and Adverse Event Reporting Program Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:05:04Z | 0 | 0 | 09000064838a4650 | |||
| FDA-2014-N-1210-3453 | FDA | None FDA-2014-N-1210 | Reference 22-Raveendranathan, D., J.C. Narayanaswamy, and S.V. Reddi, Response rate of catatonia to electroconvulsive therapy and its clinical correlates Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:00:17Z | 0 | 0 | 0900006483875e55 | |||
| FDA-2014-N-1210-3451 | FDA | None FDA-2014-N-1210 | Reference 20-Medda, P., et al., Electroconvulsive therapy in 197 patients with a severe, drug-resistant bipolar mixed state- treatment outcome and predictors of response Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:59:59Z | 0 | 0 | 0900006483875e51 | |||
| FDA-2014-N-1210-3433 | FDA | None FDA-2014-N-1210 | Reference 1- Medical Device Accessories - Describing Accessories and Classification Pathways - Guidance for Industry and FDA Staff Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:57:13Z | 0 | 0 | 0900006483875df9 | |||
| FDA-2014-N-1210-3452 | FDA | None FDA-2014-N-1210 | Reference 21-Raffin, M., et al., Treatment use in a prospective naturalistic cohort of children and adolescents with catatonia Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:00:09Z | 0 | 0 | 0900006483875e54 | |||
| FDA-2014-N-1210-3471 | FDA | None FDA-2014-N-1210 | Reference 41-Panel Transcript Jan 27-28 2011 Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:02:59Z | 0 | 0 | 0900006483875e86 | |||
| FDA-2014-N-1210-3492 | FDA | None FDA-2014-N-1210 | Reference 17-Jacob, P., et al., Review of electroconvulsive therapy practice from a tertiary Child and Adolescent Psychiatry Centre Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:23:47Z | 0 | 0 | 0900006483876152 | |||
| FDA-2014-N-1210-3461 | FDA | None FDA-2014-N-1210 | Reference 31-Zhang, Z.J., et al., Electroconvulsive therapy improves antipsychotic and somnographic responses in adolescents with first-episode psychosis--a case-control study Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:01:18Z | 0 | 0 | 0900006483876179 | |||
| FDA-2014-N-1210-3450 | FDA | None FDA-2014-N-1210 | Reference 19-Medda, P., et al., Catatonia in 26 patients with bipolar disorder- clinical features and response to electroconvulsive therapy Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:59:51Z | 0 | 0 | 0900006483876154 | |||
| FDA-2014-N-1210-3488 | FDA | None FDA-2014-N-1210 | Reference 59-de Sousa, R.T., et al., Challenging Treatment-Resistant Major Depressive Disorder- A Roadmap for Improved Therapeutics Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:05:23Z | 0 | 0 | 09000064838a4652 | |||
| FDA-2014-N-1210-3443 | FDA | None FDA-2014-N-1210 | Reference 11-Dessens, F.M., et al., Electroconvulsive therapy in the intensive care unit for the treatment of catatonia-a case series and review of the literature Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:58:46Z | 0 | 0 | 0900006483875e14 | |||
| FDA-2014-N-1210-3457 | FDA | None FDA-2014-N-1210 | Reference 27-Ghaziuddin, N., S. Dumas, and E. Hodges, Use of continuation or maintenance electroconvulsive therapy in adolescents with severe treatment-resistant depression Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:00:46Z | 0 | 0 | 0900006483875e5a | |||
| FDA-2014-N-1210-3460 | FDA | None FDA-2014-N-1210 | Reference 30-de la Serna, E., et al., Two-year follow-up of cognitive functions in schizophrenia spectrum disorders of adolescent patients treated with electroconvulsive therapy Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:01:12Z | 0 | 0 | 0900006483876177 | |||
| FDA-2014-N-1210-3470 | FDA | None FDA-2014-N-1210 | Reference 40-Ghaziuddin, N., et al., Practice parameter for use of electroconvulsive therapy with adolescents re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:02:49Z | 0 | 0 | 0900006483875e84 | |||
| FDA-2014-N-1210-3483 | FDA | None FDA-2014-N-1210 | Reference 53- Interim report of the Special Rapporteur on torture and other cruel, inhuman or degrading treatment or punishment UN Report Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:04:42Z | 0 | 0 | 0900006483875ef3 | |||
| FDA-2014-N-1210-3440 | FDA | None FDA-2014-N-1210 | Reference 8-Spaans, H.P., et al., Efficacy and cognitive side effects after brief pulse and ultrabrief pulse right unilateral electroconvulsive therapy for major depression Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:58:19Z | 0 | 0 | 0900006483875e10 | |||
| FDA-2014-N-1210-3482 | FDA | None FDA-2014-N-1210 | Reference 52-Milstein, V., et al., Does Electroconvulsive Therapy Prevent Suicide Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:04:34Z | 0 | 0 | 0900006483875ef2 | |||
| FDA-2014-N-1210-3474 | FDA | None FDA-2014-N-1210 | Reference 44-Iancu, I., et al., Patients with schizophrenia or schizoaffective disorder who receive multiple electroconvulsive therapy sessions- characteristics, indications, and results Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:03:25Z | 0 | 0 | 0900006483875e89 | |||
| FDA-2014-N-1210-3479 | FDA | None FDA-2014-N-1210 | Reference 49-Black, D.W., G. Winokur, and A. Nasrallah, ECT in Unipolar and Bipolar Disorders- A Naturalistic Evaluation of 460 Patients Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:04:06Z | 0 | 0 | 0900006483875ea7 | |||
| FDA-2014-N-1210-3485 | FDA | None FDA-2014-N-1210 | Reference 55-Texas Dept. of State Health Services Electroconvulsive Therapy (ECT) Reports Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:04:57Z | 0 | 0 | 09000064838a464f | |||
| FDA-2014-N-1210-3438 | FDA | None FDA-2014-N-1210 | Reference 6-Kirov, G.G., et al., Evaluation of cumulative cognitive deficits from electroconvulsive therapy. Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:58:00Z | 0 | 0 | 0900006483875e01 | |||
| FDA-2014-N-1210-3472 | FDA | None FDA-2014-N-1210 | Reference 42-Baeza, I., et al., Clinical experience using electroconvulsive therapy in adolescents with schizophrenia spectrum disorders Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:03:08Z | 0 | 0 | 0900006483875e87 | |||
| FDA-2014-N-1210-3462 | FDA | None FDA-2014-N-1210 | Reference 32-Cohen, D., et al., Absence of cognitive impairment at long-term follow-up in adolescents treated with ECT for severe mood disorder Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:01:26Z | 0 | 0 | 090000648387617a | |||
| FDA-2014-N-1210-3432 | FDA | None FDA-2014-N-1210 | REFERENCES LIST RE: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:56:54Z | 0 | 0 | 0900006483875df8 | |||
| FDA-2014-N-1210-3491 | FDA | None FDA-2014-N-1210 | Reference 62-Device Labeling Guidance No. G91-1 Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:05:50Z | 0 | 0 | 09000064838a4655 | |||
| FDA-2014-N-1210-3444 | FDA | None FDA-2014-N-1210 | Reference 12-England, M.L., et al., Catatonia in psychotic patients- clinical features and treatment response Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:58:57Z | 0 | 0 | 0900006483875e15 | |||
| FDA-2014-N-1210-3441 | FDA | None FDA-2014-N-1210 | Reference 9-Semkovska, M., et al., Bitemporal Versus High-Dose Unilateral Twice-Weekly Electroconvulsive Therapy for Depression (EFFECT-Dep) Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:58:30Z | 0 | 0 | 0900006483875e11 | |||
| FDA-2014-N-1210-3469 | FDA | None FDA-2014-N-1210 | Reference 39-Kutcher, S.R., HA. , Electroconvulsive therapy in treatment-resistant bipolar youth re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:02:42Z | 0 | 0 | 0900006483875e83 | |||
| FDA-2014-N-1210-3487 | FDA | None FDA-2014-N-1210 | Reference 57-Neurological Devices Panel ECT - Janu 2011 24 Hour Summary Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:05:13Z | 0 | 0 | 09000064838a4651 | |||
| FDA-2014-N-1210-3447 | FDA | None FDA-2014-N-1210 | Referrence 15-Ghaziuddin, N., D. Dhossche, and K. Marcotte, Retrospective chart review of catatonia in child and adolescent psychiatric patients Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:59:24Z | 0 | 0 | 0900006483875e18 | |||
| FDA-2014-N-1210-3446 | FDA | None FDA-2014-N-1210 | Reference 14-Flamarique, I., et al., Long-term effectiveness of electroconvulsive therapy in adolescents with schizophrenia spectrum disorders Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:59:13Z | 0 | 0 | 0900006483875e17 | |||
| FDA-2014-N-1210-3464 | FDA | None FDA-2014-N-1210 | Reference 34-Rey, J.M. and G. Walter, Half a century of ECT use in young people Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:01:46Z | 0 | 0 | 090000648387617c | |||
| FDA-2014-N-1210-3456 | FDA | None FDA-2014-N-1210 | Reference 26-Hasan, A., et al., World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Schizophrenia, part 1 Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:00:38Z | 0 | 0 | 0900006483875e59 | |||
| FDA-2014-N-1210-3445 | FDA | None FDA-2014-N-1210 | Reference 13-Faedda, G.L., et al., Catatonia in an adolescent with velo-cardio-facial syndrome Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:59:05Z | 0 | 0 | 0900006483875e16 | |||
| FDA-2014-N-1210-3435 | FDA | None FDA-2014-N-1210 | Reference 3-Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:57:31Z | 0 | 0 | 0900006483875dfb | |||
| FDA-2014-N-1210-3490 | FDA | None FDA-2014-N-1210 | Reference 61-Diagnostic and Statistical Manual of Mental Disorders Fifth Edition DSM-5 Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:05:42Z | 0 | 0 | 09000064838a4654 | |||
| FDA-2014-N-1210-3480 | FDA | None FDA-2014-N-1210 | Reference 50-Mukherjee, S. and V. Debsikdar, Unmodified Electroconvulsive Therapy of Acute Mania- A Retrospective Naturalistic Study Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:04:15Z | 0 | 0 | 0900006483875ea8 | |||
| FDA-2014-N-1210-3468 | FDA | None FDA-2014-N-1210 | Reference 38-Cohen, D., M.L. Paillere-Martinot, and M. Basquin, Use of electroconvulsive therapy in adolescents Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:02:34Z | 0 | 0 | 0900006483875e82 | |||
| FDA-2014-N-1210-3475 | FDA | None FDA-2014-N-1210 | Reference 45-Kristensen, D., et al., Electroconvulsive therapy for treating schizophrenia- a chart review of patients from two catchment areas Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:03:33Z | 0 | 0 | 0900006483875e8a | |||
| FDA-2014-N-1210-3466 | FDA | None FDA-2014-N-1210 | Reference 36-Ghaziuddin, N., et al., Electroconvulsive treatment in adolescents with pharmacotherapy-refractory depression Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:02:01Z | 0 | 0 | 090000648387617e | |||
| FDA-2014-N-1210-3473 | FDA | None FDA-2014-N-1210 | Reference 43-Benzoni, O.e.a., Treatment of resistant mood and schizoaffective disorders with electroconvulsive therapy Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:03:17Z | 0 | 0 | 0900006483875e88 | |||
| FDA-2014-N-1210-3448 | FDA | None FDA-2014-N-1210 | Reference 16-Haq, A.U. and N. Ghaziuddin, Maintenance electroconvulsive therapy for aggression and self-injurious behavior in two adolescents with autism and catatonia Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T20:59:31Z | 0 | 0 | 0900006483876151 | |||
| FDA-2014-N-1210-3476 | FDA | None FDA-2014-N-1210 | Reference 46-Levy-Rueff, M., et al., Maintenance electroconvulsive therapy- an alternative treatment for refractory schizophrenia and schizoaffective disorders Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:03:40Z | 0 | 0 | 0900006483875e9f | |||
| FDA-2014-N-1210-3484 | FDA | None FDA-2014-N-1210 | Reference 54 - Mental Health - A Report of the Surgeon General Re: Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Supporting & Related Material | Background Material | 2019-03-05T05:00:00Z | 2019 | 3 | 2019-03-05T21:04:49Z | 0 | 0 | 0900006483875ef5 | |||
| FDA-2014-N-1210-3431 | FDA | None FDA-2014-N-1210 | Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses | Rule | Final Rule | 2018-12-26T05:00:00Z | 2018 | 12 | 2018-12-26T05:00:00Z | 2019-01-10T02:12:36Z | 2018-27809 | 0 | 0 | 09000064839c4d26 | |
| FDA-2014-N-1210-0003 | FDA | None FDA-2014-N-1210 | Reference 1 - The Practice of Electroconvulsive Therapy - Recommendations for Treatment, Training and Privileging | Supporting & Related Material | Reference (external attachments) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:24:31Z | 0 | 0 | 0900006481dd8bf6 | |||
| FDA-2014-N-1210-0009 | FDA | None FDA-2014-N-1210 | Reference 7 - Antidepressant Drug Effects and Depression Severity: A Patient-Level Meta-Analysis | Supporting & Related Material | Reference (external attachments) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:23:16Z | 0 | 0 | 0900006481dd8c8e | |||
| FDA-2014-N-1210-0011 | FDA | None FDA-2014-N-1210 | Reference 9 - An Examination of Mortality and Other Adverse Events Related to Electroconvulsive Therapy Using a National Adverse Event Report System | Supporting & Related Material | Reference (external attachments) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:22:54Z | 0 | 0 | 0900006481dd8e03 | |||
| FDA-2014-N-1210-0006 | FDA | None FDA-2014-N-1210 | Reference 4 - Mental Health - A Report of the Surgeon General | Supporting & Related Material | Reference (external attachments) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:23:50Z | 0 | 0 | 0900006481dd8c8b | |||
| FDA-2014-N-1210-0004 | FDA | None FDA-2014-N-1210 | Reference 2 - Guidance on the Use of Electroconvulsive Therapy | Supporting & Related Material | Reference (external attachments) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:24:16Z | 0 | 0 | 0900006481dd8bfa | |||
| FDA-2014-N-1210-0008 | FDA | None FDA-2014-N-1210 | Reference 6 - Clinical and Cost-Effectiveness of Electroconvulsive Therapy for Depressive Illness, Schizophrenia, Catatonia and Mania-Systematic Reviews and Economic Modelling Studies | Supporting & Related Material | Reference (external attachments) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:23:27Z | 0 | 0 | 0900006481dd8c8d | |||
| FDA-2014-N-1210-0007 | FDA | None FDA-2014-N-1210 | Reference 5 - Objective Cognitive Performance Associated with Electroconvulsive Therapy for Depression- A Systematic Review and Meta-Analysis | Supporting & Related Material | Reference (external attachments) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:23:38Z | 0 | 0 | 0900006481dd8c8c | |||
| FDA-2014-N-1210-0010 | FDA | None FDA-2014-N-1210 | Reference 8 - Initial Severity and Antidepressant Benefits- A Meta-Analysis of Data Submitted to the Food and Drug Administration | Supporting & Related Material | Reference (external attachments) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:23:04Z | 0 | 0 | 0900006481dd8e02 | |||
| FDA-2014-N-1210-0002 | FDA | None FDA-2014-N-1210 | List of References for Reclassification of Electroconvulsive Therapy (ECT) Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for ECT Devices for Certain Specified Intended Uses Proposed Order | Supporting & Related Material | List | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:24:43Z | 0 | 0 | 0900006481dd8bf5 | |||
| FDA-2014-N-1210-0005 | FDA | None FDA-2014-N-1210 | Reference 3 - Depression in Adults - The Treatment and Management of Depression in Adults | Supporting & Related Material | Reference (external attachments) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:24:01Z | 0 | 0 | 0900006481dd8bfb | |||
| FDA-2014-N-1210-0001 | FDA | None FDA-2014-N-1210 | Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy for Certain Specified Intended Uses | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T05:00:00Z | 2016-03-29T03:59:59Z | 2019-01-14T20:50:27Z | 2015-32592 | 0 | 0 | 0900006481dd79bf |
| FDA-2014-N-1210-0012 | FDA | None FDA-2014-N-1210 | Reference 10 - Electroconvulsive Therapy in Lorazepam Non-Responsive Catatonia | Supporting & Related Material | Reference (external attachments) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:22:43Z | 0 | 0 | 0900006481dd8e0a | |||
| FDA-2014-N-1210-0013 | FDA | None FDA-2014-N-1210 | Reference 11 - FDA Executive Summary - Prepared for the March 17, 2011 Meeting of the Neurologic Devices Panel | Supporting & Related Material | Reference (internal unless indicated) | 2015-12-29T05:00:00Z | 2015 | 12 | 2015-12-29T17:22:32Z | 0 | 0 | 0900006481dd8e0b |
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