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12 rows where docket_id = "FDA-2014-N-1209" sorted by posted_date descending
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document_type 3
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- FDA 12
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-1209-0315 | FDA | None FDA-2014-N-1209 | Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Devices Intended To Treat Anxiety and/ or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended To Treat Depression | Rule | Final Rule | 2019-12-20T05:00:00Z | 2019 | 12 | 2019-12-20T05:00:00Z | 2019-12-20T13:47:06Z | 2019-27295 | 0 | 0 | 0900006484240022 | |
| FDA-2014-N-1209-0313 | FDA | None FDA-2014-N-1209 | Fisher Wallace Memo January 9 | Supporting & Related Material | Memorandum | 2017-02-02T05:00:00Z | 2017 | 2 | 2017-02-02T14:47:31Z | 0 | 0 | 09000064824a545f | |||
| FDA-2014-N-1209-0314 | FDA | None FDA-2014-N-1209 | Letter accompanying Submission to Proposed Order Docket FWL | Supporting & Related Material | Letter | 2017-02-02T05:00:00Z | 2017 | 2 | 2017-02-02T14:48:12Z | 0 | 0 | 09000064824a5460 | |||
| FDA-2014-N-1209-0003 | FDA | None FDA-2014-N-1209 | Reference 33, Studies of Electrosleep on Normal Adults, Insomniacs, and Hypertensive Patients re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression | Supporting & Related Material | Background Material | 2016-01-22T05:00:00Z | 2016 | 1 | 2016-01-22T17:55:45Z | 0 | 0 | 0900006481e2919e | |||
| FDA-2014-N-1209-0005 | FDA | None FDA-2014-N-1209 | Reference 31, Does Electrosleep Induce Natural Sleep? re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression | Supporting & Related Material | Background Material | 2016-01-22T05:00:00Z | 2016 | 1 | 2016-01-22T17:56:07Z | 0 | 0 | 0900006481e2919c | |||
| FDA-2014-N-1209-0001 | FDA | None FDA-2014-N-1209 | Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2016-01-22T05:00:00Z | 2016 | 1 | 2016-01-22T05:00:00Z | 2016-04-22T03:59:59Z | 2016-06-15T01:00:33Z | 2016-01173 | 0 | 0 | 0900006481e2882d |
| FDA-2014-N-1209-0007 | FDA | None FDA-2014-N-1209 | Reference 30 Quantitative EEG Analysis of Electrosleep Using Analog Frequency Analyzer and Digital Computer Methods re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression | Supporting & Related Material | Background Material | 2016-01-22T05:00:00Z | 2016 | 1 | 2016-01-22T17:57:04Z | 0 | 0 | 0900006481e29196 | |||
| FDA-2014-N-1209-0009 | FDA | None FDA-2014-N-1209 | Reference 2 - FDA Executive Summary, Prepared for the February 10, 2012, meeting of the Neurological Devices Panel re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression | Supporting & Related Material | Background Material | 2016-01-22T05:00:00Z | 2016 | 1 | 2016-01-22T18:05:28Z | 0 | 0 | 0900006481e28c87 | |||
| FDA-2014-N-1209-0006 | FDA | None FDA-2014-N-1209 | Reference 35, A Clinical Trial of Cranial Electrotherapy Stimulation for Anxiety and Comorbid Depression re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression | Supporting & Related Material | Background Material | 2016-01-22T05:00:00Z | 2016 | 1 | 2016-01-22T17:56:55Z | 0 | 0 | 0900006481e290f4 | |||
| FDA-2014-N-1209-0002 | FDA | None FDA-2014-N-1209 | List of References re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression | Supporting & Related Material | Background Material | 2016-01-22T05:00:00Z | 2016 | 1 | 2016-01-22T17:55:33Z | 0 | 0 | 0900006481e28c37 | |||
| FDA-2014-N-1209-0004 | FDA | None FDA-2014-N-1209 | Reference 32, Ineffectiveness of Elctrosleep in Chronic Primary Insomnia re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression | Supporting & Related Material | Background Material | 2016-01-22T05:00:00Z | 2016 | 1 | 2016-01-22T17:55:56Z | 0 | 0 | 0900006481e2919d | |||
| FDA-2014-N-1209-0008 | FDA | None FDA-2014-N-1209 | Reference 1 - Transcript, February 10, 2012, meeting of the Neurological Devices Panel of the Medical Device Advisory Committee re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression | Supporting & Related Material | Background Material | 2016-01-22T05:00:00Z | 2016 | 1 | 2016-01-22T18:03:24Z | 0 | 0 | 0900006481e28c86 |
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id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
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CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;