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63 rows where docket_id = "FDA-2014-N-1210" and posted_year = 2019 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 |
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