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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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