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withdrawn,object_id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