{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where docket_id = \"FDA-2014-N-1210\" and posted_year = 2019 sorted by posted_date descending", "rows": [["FDA-2014-N-1210-3494", "FDA", "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, null, null, "2019-03-06T15:33:14Z", null, 0, 0, "0900006483ac3808"], ["FDA-2014-N-1210-3493", "FDA", "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, null, null, "2019-03-06T15:33:05Z", null, 0, 0, "0900006483ac3807"], ["FDA-2014-N-1210-3449", "FDA", "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, null, null, "2019-03-05T20:59:45Z", null, 0, 0, "0900006483876153"], ["FDA-2014-N-1210-3434", "FDA", "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, null, null, "2019-03-05T20:57:24Z", null, 0, 0, "0900006483875dfa"], ["FDA-2014-N-1210-3436", "FDA", "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, null, null, "2019-03-05T20:57:41Z", null, 0, 0, "0900006483875dfc"], ["FDA-2014-N-1210-3477", "FDA", "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, null, null, "2019-03-05T21:03:49Z", null, 0, 0, "0900006483875ea0"], ["FDA-2014-N-1210-3478", "FDA", "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, null, null, "2019-03-05T21:03:58Z", null, 0, 0, "0900006483875ea1"], ["FDA-2014-N-1210-3481", "FDA", "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, null, null, "2019-03-05T21:04:24Z", null, 0, 0, "0900006483875ef1"], ["FDA-2014-N-1210-3459", "FDA", "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, null, null, "2019-03-05T21:01:03Z", null, 0, 0, "0900006483876176"], ["FDA-2014-N-1210-3463", "FDA", "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, null, null, "2019-03-05T21:01:38Z", null, 0, 0, "090000648387617b"], ["FDA-2014-N-1210-3455", "FDA", "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, null, null, "2019-03-05T21:00:31Z", null, 0, 0, "0900006483875e58"], ["FDA-2014-N-1210-3454", "FDA", "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, null, null, "2019-03-05T21:00:23Z", null, 0, 0, "0900006483875e56"], ["FDA-2014-N-1210-3437", "FDA", "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, null, null, "2019-03-05T20:57:53Z", null, 0, 0, "0900006483875dfd"], ["FDA-2014-N-1210-3489", "FDA", "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, null, null, "2019-03-05T21:05:34Z", null, 0, 0, "09000064838a4653"], ["FDA-2014-N-1210-3458", "FDA", "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, null, null, "2019-03-05T21:00:53Z", null, 0, 0, "0900006483876175"], ["FDA-2014-N-1210-3465", "FDA", "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, null, null, "2019-03-05T21:01:53Z", null, 0, 0, "090000648387617d"], ["FDA-2014-N-1210-3439", "FDA", "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, null, null, "2019-03-05T20:58:08Z", null, 0, 0, "0900006483875e0f"], ["FDA-2014-N-1210-3442", "FDA", "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, null, null, "2019-03-05T20:58:38Z", null, 0, 0, "0900006483875e12"], ["FDA-2014-N-1210-3467", "FDA", "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, null, null, "2019-03-05T21:02:26Z", null, 0, 0, "0900006483875e81"], ["FDA-2014-N-1210-3486", "FDA", "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, null, null, "2019-03-05T21:05:04Z", null, 0, 0, "09000064838a4650"], ["FDA-2014-N-1210-3453", "FDA", "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, null, null, "2019-03-05T21:00:17Z", null, 0, 0, "0900006483875e55"], ["FDA-2014-N-1210-3451", "FDA", "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, null, null, "2019-03-05T20:59:59Z", null, 0, 0, "0900006483875e51"], ["FDA-2014-N-1210-3433", "FDA", "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, null, null, "2019-03-05T20:57:13Z", null, 0, 0, "0900006483875df9"], ["FDA-2014-N-1210-3452", "FDA", "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, null, null, "2019-03-05T21:00:09Z", null, 0, 0, "0900006483875e54"], ["FDA-2014-N-1210-3471", "FDA", "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, null, null, "2019-03-05T21:02:59Z", null, 0, 0, "0900006483875e86"], ["FDA-2014-N-1210-3492", "FDA", "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, null, null, "2019-03-05T21:23:47Z", null, 0, 0, "0900006483876152"], ["FDA-2014-N-1210-3461", "FDA", "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, null, null, "2019-03-05T21:01:18Z", null, 0, 0, "0900006483876179"], ["FDA-2014-N-1210-3450", "FDA", "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, null, null, "2019-03-05T20:59:51Z", null, 0, 0, "0900006483876154"], ["FDA-2014-N-1210-3488", "FDA", "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, null, null, "2019-03-05T21:05:23Z", null, 0, 0, "09000064838a4652"], ["FDA-2014-N-1210-3443", "FDA", "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, null, null, "2019-03-05T20:58:46Z", null, 0, 0, "0900006483875e14"], ["FDA-2014-N-1210-3457", "FDA", "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, null, null, "2019-03-05T21:00:46Z", null, 0, 0, "0900006483875e5a"], ["FDA-2014-N-1210-3460", "FDA", "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, null, null, "2019-03-05T21:01:12Z", null, 0, 0, "0900006483876177"], ["FDA-2014-N-1210-3470", "FDA", "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, null, null, "2019-03-05T21:02:49Z", null, 0, 0, "0900006483875e84"], ["FDA-2014-N-1210-3483", "FDA", "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, null, null, "2019-03-05T21:04:42Z", null, 0, 0, "0900006483875ef3"], ["FDA-2014-N-1210-3440", "FDA", "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, null, null, "2019-03-05T20:58:19Z", null, 0, 0, "0900006483875e10"], ["FDA-2014-N-1210-3482", "FDA", "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, null, null, "2019-03-05T21:04:34Z", null, 0, 0, "0900006483875ef2"], ["FDA-2014-N-1210-3474", "FDA", "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, null, null, "2019-03-05T21:03:25Z", null, 0, 0, "0900006483875e89"], ["FDA-2014-N-1210-3479", "FDA", "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, null, null, "2019-03-05T21:04:06Z", null, 0, 0, "0900006483875ea7"], ["FDA-2014-N-1210-3485", "FDA", "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, null, null, "2019-03-05T21:04:57Z", null, 0, 0, "09000064838a464f"], ["FDA-2014-N-1210-3438", "FDA", "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, null, null, "2019-03-05T20:58:00Z", null, 0, 0, "0900006483875e01"], ["FDA-2014-N-1210-3472", "FDA", "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, null, null, "2019-03-05T21:03:08Z", null, 0, 0, "0900006483875e87"], ["FDA-2014-N-1210-3462", "FDA", "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, null, null, "2019-03-05T21:01:26Z", null, 0, 0, "090000648387617a"], ["FDA-2014-N-1210-3432", "FDA", "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, null, null, "2019-03-05T20:56:54Z", null, 0, 0, "0900006483875df8"], ["FDA-2014-N-1210-3491", "FDA", "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, null, null, "2019-03-05T21:05:50Z", null, 0, 0, "09000064838a4655"], ["FDA-2014-N-1210-3444", "FDA", "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, null, null, "2019-03-05T20:58:57Z", null, 0, 0, "0900006483875e15"], ["FDA-2014-N-1210-3441", "FDA", "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, null, null, "2019-03-05T20:58:30Z", null, 0, 0, "0900006483875e11"], ["FDA-2014-N-1210-3469", "FDA", "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, null, null, "2019-03-05T21:02:42Z", null, 0, 0, "0900006483875e83"], ["FDA-2014-N-1210-3487", "FDA", "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, null, null, "2019-03-05T21:05:13Z", null, 0, 0, "09000064838a4651"], ["FDA-2014-N-1210-3447", "FDA", "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, null, null, "2019-03-05T20:59:24Z", null, 0, 0, "0900006483875e18"], ["FDA-2014-N-1210-3446", "FDA", "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, null, null, "2019-03-05T20:59:13Z", null, 0, 0, "0900006483875e17"], ["FDA-2014-N-1210-3464", "FDA", "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, null, null, "2019-03-05T21:01:46Z", null, 0, 0, "090000648387617c"], ["FDA-2014-N-1210-3456", "FDA", "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, null, null, "2019-03-05T21:00:38Z", null, 0, 0, "0900006483875e59"], ["FDA-2014-N-1210-3445", "FDA", "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, null, null, "2019-03-05T20:59:05Z", null, 0, 0, "0900006483875e16"], ["FDA-2014-N-1210-3435", "FDA", "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, null, null, "2019-03-05T20:57:31Z", null, 0, 0, "0900006483875dfb"], ["FDA-2014-N-1210-3490", "FDA", "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, null, null, "2019-03-05T21:05:42Z", null, 0, 0, "09000064838a4654"], ["FDA-2014-N-1210-3480", "FDA", "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, null, null, "2019-03-05T21:04:15Z", null, 0, 0, "0900006483875ea8"], ["FDA-2014-N-1210-3468", "FDA", "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, null, null, "2019-03-05T21:02:34Z", null, 0, 0, "0900006483875e82"], ["FDA-2014-N-1210-3475", "FDA", "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, null, null, "2019-03-05T21:03:33Z", null, 0, 0, "0900006483875e8a"], ["FDA-2014-N-1210-3466", "FDA", "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, null, null, "2019-03-05T21:02:01Z", null, 0, 0, "090000648387617e"], ["FDA-2014-N-1210-3473", "FDA", "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, null, null, "2019-03-05T21:03:17Z", null, 0, 0, "0900006483875e88"], ["FDA-2014-N-1210-3448", "FDA", "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, null, null, "2019-03-05T20:59:31Z", null, 0, 0, "0900006483876151"], ["FDA-2014-N-1210-3476", "FDA", "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, null, null, "2019-03-05T21:03:40Z", null, 0, 0, "0900006483875e9f"], ["FDA-2014-N-1210-3484", "FDA", "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, null, null, "2019-03-05T21:04:49Z", null, 0, 0, "0900006483875ef5"]], "truncated": false, "filtered_table_rows_count": 63, "expanded_columns": [], "expandable_columns": [[{"column": "docket_id", "other_table": "dockets", "other_column": "id"}, "title"]], "columns": ["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"], "primary_keys": ["id"], "units": {}, "query": {"sql": "select 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 from documents where \"docket_id\" = :p0 and \"posted_year\" = :p1 order by posted_date desc limit 101", "params": {"p0": "FDA-2014-N-1210", "p1": "2019"}}, "facet_results": {"agency_id": {"name": "agency_id", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-2014-N-1210&posted_year=2019", "results": [{"value": "FDA", "label": "FDA", "count": 63, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2014-N-1210&posted_year=2019&agency_id=FDA", "selected": false}], "truncated": false}, "document_type": {"name": "document_type", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-2014-N-1210&posted_year=2019", "results": [{"value": "Supporting & Related Material", "label": "Supporting & Related Material", "count": 63, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2014-N-1210&posted_year=2019&document_type=Supporting+%26+Related+Material", "selected": false}], "truncated": false}, "posted_year": {"name": "posted_year", "type": "column", "hideable": false, "toggle_url": "/openregs/documents.json?docket_id=FDA-2014-N-1210&posted_year=2019", "results": [{"value": 2019, "label": 2019, "count": 63, "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2014-N-1210", "selected": true}], "truncated": false}}, "suggested_facets": [{"name": "posted_date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2014-N-1210&posted_year=2019&_facet=posted_date"}, {"name": "posted_date", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2014-N-1210&posted_year=2019&_facet_date=posted_date"}, {"name": "last_modified", "type": "date", "toggle_url": "https://www.pawtectors.org/openregs/documents.json?docket_id=FDA-2014-N-1210&posted_year=2019&_facet_date=last_modified"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 2213.6678430251777, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}