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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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55 rows where docket_id = "FDA-2010-P-0176" sorted by posted_date descending

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id agency_id docket_id title document_type subtype posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id
FDA-2010-P-0176-0086 FDA None FDA-2010-P-0176 SEDASYS Computer-Assisted Personalized Sedation System: Ethicon Endo-Surgery, Inc. Petition for Review of Denial of Premarket Approval; Meeting Cancellation Notice General Notice 2011-12-05T05:00:00Z 2011 12 2011-12-05T05:00:00Z   2011-12-05T14:42:36Z 2011-31105 0 0 0900006480f7b64c
FDA-2010-P-0176-0085 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) to FDA/OC/CDRH, Widrawal of Request for Administrative Review of CDRH's Denial Order for the SEDASYS System PMA (P080009) Other Withdrawal 2011-11-30T05:00:00Z 2011 11 2011-11-30T05:00:00Z   2011-12-01T16:23:48Z   0 0 0900006480f771ad
FDA-2010-P-0176-0084 FDA None FDA-2010-P-0176 SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s Petition for Review of FDA's Denial of Premarket Approval - Notice of Meeting Notice Meeting 2011-11-21T05:00:00Z 2011 11 2011-11-21T05:00:00Z 2011-12-08T04:59:59Z 2011-11-28T15:18:41Z 2011-29888 0 0 0900006480f70910
FDA-2010-P-0176-0083 FDA None FDA-2010-P-0176 FDA/CDRH Ombudsman to Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) and Staff Attorney, Response to October 11, 2011 - Letter Other Letter(s) 2011-11-01T04:00:00Z 2011 11 2011-11-01T04:00:00Z   2011-11-01T13:05:08Z   0 0 0900006480f63c33
FDA-2010-P-0176-0079 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, Inc. (EES) (Goodwin Procter LLP) - Letter Other Letter(s) 2011-10-25T04:00:00Z 2011 10 2011-10-25T04:00:00Z   2013-08-11T04:48:08Z   0 0 0900006480f53ee0
FDA-2010-P-0176-0076 FDA None FDA-2010-P-0176 FDA/Office for Policy to the Division of Dockets Management re Separation of Functions, 9/26/2011 - Memorandum Other Memorandum 2011-09-27T04:00:00Z 2011 9 2011-09-27T04:00:00Z   2011-09-27T19:22:23Z   0 0 0900006480f3e26d
FDA-2010-P-0176-0075 FDA None FDA-2010-P-0176 FDA/CDRH Ombudsman to Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) and Staff Attorney Letter with Attached Summary of Scientific Issues - Summary Other Summary (SUM) 2011-09-14T04:00:00Z 2011 9 2011-09-14T04:00:00Z   2011-09-14T12:27:03Z   0 0 0900006480f1748c
FDA-2010-P-0176-0072 FDA None FDA-2010-P-0176 FDA/CDRH Ombudsman to Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) and Staff Attorney, Letter With Attached Schedule of Events and Agenda, September 9, 2011 - Letter Other List (LST) 2011-09-09T04:00:00Z 2011 9 2011-09-09T04:00:00Z   2011-09-09T16:06:35Z   0 0 0900006480f14ffc
FDA-2010-P-0176-0069 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, (EES) Inc. (Goodwin Proctor, LLP) - Letter Other Letter(s) 2011-09-07T04:00:00Z 2011 9 2011-09-07T04:00:00Z   2011-09-07T22:50:09Z   0 0 0900006480f12488
FDA-2010-P-0176-0068 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, (EES) Inc. (Goodwin Proctor, LLP) - Letter Other Letter(s) 2011-09-07T04:00:00Z 2011 9 2011-09-07T04:00:00Z   2013-08-11T04:47:31Z   0 0 0900006480f0ef0c
FDA-2010-P-0176-0067 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, (EES) Inc. (Goodwin Proctor, LLP) - Letter Other Letter(s) 2011-09-07T04:00:00Z 2011 9 2011-09-07T04:00:00Z   2013-08-11T04:47:22Z   0 0 0900006480ee9dfd
FDA-2010-P-0176-0066 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, (EES) Inc. (Goodwin Proctor, LLP) - Letter Other Letter(s) 2011-09-07T04:00:00Z 2011 9 2011-09-07T04:00:00Z   2013-08-11T01:42:49Z   0 0 0900006480ec9f1c
FDA-2010-P-0176-0065 FDA None FDA-2010-P-0176 FDA/Office for Policy to the Division of Dockets Management re Separation of Functions, 9/1/2011 - Memorandum Other Memorandum 2011-09-06T04:00:00Z 2011 9 2011-09-06T04:00:00Z   2011-09-06T17:57:53Z   0 0 0900006480f1216a
FDA-2010-P-0176-0064 FDA None FDA-2010-P-0176 FDA/CDRH Response to the Summary of Scientific Issues and Schedule of Events - Letter Other Letter(s) 2011-09-02T04:00:00Z 2011 9 2011-09-02T04:00:00Z   2011-09-02T13:11:26Z   0 0 0900006480f0e7f0
FDA-2010-P-0176-0063 FDA None FDA-2010-P-0176 FDA/Office for Policy and Goodwin Proctor LLP to Lawrence Romanell, Deputy Ombudsman CDRH, August 29, 2011 - Letter Other Letter(s) 2011-08-30T04:00:00Z 2011 8 2011-08-30T04:00:00Z   2011-08-30T12:31:04Z   0 0 0900006480f08bd2
FDA-2010-P-0176-0062 FDA None FDA-2010-P-0176 FDA/CDRH letter to Mr. Buckles, dated August 26, 2011 - Letter Other Letter(s) 2011-08-29T04:00:00Z 2011 8 2011-08-29T04:00:00Z   2024-11-07T22:38:10Z   1 0 0900006480f07665
FDA-2010-P-0176-0061 FDA None FDA-2010-P-0176 FDA/CDRH List of Attendees; Docket No. FDA-2010-P-0176 - List Other List (LST) 2011-08-23T04:00:00Z 2011 8 2011-08-23T04:00:00Z   2011-08-23T19:44:37Z   0 0 0900006480eea8d7
FDA-2010-P-0176-0060 FDA None FDA-2010-P-0176 FDA/CDRH List of Attendees; Docket No. FDA-2010-P-0176 - List Other List (LST) 2011-08-19T04:00:00Z 2011 8     2011-08-19T16:51:13Z   0 0 0900006480ee5d82
FDA-2010-P-0176-0058 FDA None FDA-2010-P-0176 FDA/CDRH and Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP to Center for Devices and Radiological Health - Letter Other Letter(s) 2011-08-15T04:00:00Z 2011 8 2011-08-15T04:00:00Z   2011-11-04T23:19:57Z   0 0 0900006480ee102d
FDA-2010-P-0176-0059 FDA None FDA-2010-P-0176 FDA/CDRH Ombudsman to Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) and Staff Attorney Letter with Attached Final Version of Summary of the Scientific Issues in Dispute Other Letter(s) 2011-08-15T04:00:00Z 2011 8 2011-08-15T04:00:00Z   2011-08-15T17:02:40Z   0 0 0900006480ee1031
FDA-2010-P-0176-0057 FDA None FDA-2010-P-0176 FDA/CDRH Ombudsman to Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) and Staff Attorney, re Revised Schedule of Events - Letter Other List (LST) 2011-08-10T04:00:00Z 2011 8 2011-08-10T04:00:00Z   2011-08-10T15:22:23Z   0 0 0900006480edcd39
FDA-2010-P-0176-0056 FDA None FDA-2010-P-0176 FDA/CDRH Ombudsman to Dockets Management re Separation of Functions, August 8, 2011 - Memorandum Other Memorandum 2011-08-08T04:00:00Z 2011 8 2011-08-08T04:00:00Z   2011-08-08T21:21:30Z   0 0 0900006480eda7fa
FDA-2010-P-0176-0054 FDA None FDA-2010-P-0176 FDA/CDRH Ombudsman to Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) and Staff Attorney, re Schedule of Events - Letter Other List (LST) 2011-07-21T04:00:00Z 2011 7 2011-07-21T04:00:00Z   2011-07-21T14:40:55Z   0 0 0900006480ec8274
FDA-2010-P-0176-0053 FDA None FDA-2010-P-0176 Keith Denning, CRNA - Supplement re FDA-2010-P-0176-0012 Other Supplement (SUP) 2011-07-18T04:00:00Z 2011 7 2011-07-18T04:00:00Z   2016-10-31T15:02:33Z   0 0 0900006480c66d9e
FDA-2010-P-0176-0044 FDA None FDA-2010-P-0176 FDA/CDRH Summary of Scientific Issues - Letter Other Letter(s) 2011-07-11T04:00:00Z 2011 7 2011-07-11T04:00:00Z   2013-08-11T04:46:36Z   0 0 0900006480eb8443
FDA-2010-P-0176-0043 FDA None FDA-2010-P-0176 FDA/Office for Policy to the Division of Dockets Management re Statement of Issues (DRAFT), July 1, 2011 - Statement Other Statement 2011-07-08T04:00:00Z 2011 7 2011-07-08T04:00:00Z   2011-07-08T22:22:17Z   0 0 0900006480ebd5c6
FDA-2010-P-0176-0042 FDA None FDA-2010-P-0176 FDA/Office for Policy to Goodwin Proctor LLP, June 22, 2011 - Letter Other Letter(s) 2011-07-05T04:00:00Z 2011 7 2011-07-05T04:00:00Z   2011-07-05T19:39:24Z   0 0 0900006480eb99a3
FDA-2010-P-0176-0040 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) Response to FDA/Office for Policy, June 3, 2011 - Letter Other LET-Letter 2011-06-06T04:00:00Z 2011 6 2011-06-06T04:00:00Z   2011-06-06T21:14:19Z   0 0 0900006480e3cf06
FDA-2010-P-0176-0039 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) Response to FDA/Office for Policy, June 3, 2011 - Letter Other LET-Letter 2011-06-06T04:00:00Z 2011 6 2011-06-06T04:00:00Z   2011-06-06T21:12:46Z   0 0 0900006480e3cf02
FDA-2010-P-0176-0038 FDA None FDA-2010-P-0176 FDA/CDRH Ombudsman to Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) and Staff Attorney, June 2, 2011 - Letter Other LET-Letter 2011-06-03T04:00:00Z 2011 6 2011-06-03T04:00:00Z 2011-07-06T03:59:59Z 2011-09-14T12:04:18Z   0 0 0900006480e3a6b0
FDA-2010-P-0176-0030 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) to FDA/CDRH Ombudsman, April 7, 2011 - Letter Other LET-Letter 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-07-27T23:53:44Z   0 0 0900006480de9199
FDA-2010-P-0176-0025 FDA None FDA-2010-P-0176 FDA/CDRH Ombudsman Response to Ethicon Endo-Surgery, Inc., November 18, 2010 - Letter Other LET-Letter 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-08-11T01:41:47Z   0 0 0900006480ddf990
FDA-2010-P-0176-0019 FDA None FDA-2010-P-0176 Exhibit E - "Excerpts From PMA Amendment 6 - August 22, 2008" - [Ethicon Endo-Surgery, Inc. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2011-05-24T04:00:00Z 2011 5     2011-05-24T23:05:41Z   0 0 0900006480e3178b
FDA-2010-P-0176-0034 FDA None FDA-2010-P-0176 FDA/Office for Policy to Staff Attorneys re Separation of Functions, April 28, 2011 - Memorandum Other M-Memorandum 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-07-27T23:53:44Z   0 0 0900006480de9198
FDA-2010-P-0176-0023 FDA None FDA-2010-P-0176 Goodwin Procter LLP to FDA, May 17, 2010 - Memorandum Other M-Memorandum 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-08-11T03:09:04Z   0 0 0900006480b03884
FDA-2010-P-0176-0024 FDA None FDA-2010-P-0176 FDA/Office for Policy Response to Ethicon Endo-Surgery (EES), Inc., November 5, 2010 - Petition Denial Other PDN-Petition Denial 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-07-27T23:36:45Z   0 0 0900006480b830cd
FDA-2010-P-0176-0022 FDA None FDA-2010-P-0176 Acknowledgement Letter to Ethicon Endo-Surgery, Inc. - Correction Other CR-Correction 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-07-27T23:13:42Z   0 0 0900006480acb76f
FDA-2010-P-0176-0020 FDA None FDA-2010-P-0176 Exhibit F - "Excerpts From PMA Amendment 12 - June 24, 2009" - [Ethicon Endo-Surgery, Inc. - Petition for Reconsideration ] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2011-05-24T04:00:00Z 2011 5     2011-05-24T23:05:43Z   0 0 0900006480e3178c
FDA-2010-P-0176-0017 FDA None FDA-2010-P-0176 Exhibit C - "Excerpts From FDA Advisory Panel - May 28, 2009" - [Ethicon Endo-Surgery, Inc. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2011-05-24T04:00:00Z 2011 5     2011-05-24T23:00:21Z   0 0 0900006480aca0c9
FDA-2010-P-0176-0021 FDA None FDA-2010-P-0176 Acknowledgement Letter to Ethicon Endo-Surgery, Inc. Other ACK-Acknowledgement Letter 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-07-27T23:13:33Z   0 0 0900006480aca0fe
FDA-2010-P-0176-0027 FDA None FDA-2010-P-0176 FDA/Office for Policy Response to Goodwin Proctor LLP, March 17, 2011 - Letter Other LET-Letter 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-08-11T01:41:47Z   0 0 0900006480ddf993
FDA-2010-P-0176-0031 FDA None FDA-2010-P-0176 FDA/CDRH Ombudsman to Dockets Management re Teleconference Between Goodwin Procter and CDRH, April 21, 2011 - Memorandum Other M-Memorandum 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-07-27T23:53:44Z   0 0 0900006480de919a
FDA-2010-P-0176-0026 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) Response to FDA/CDRH Ombudsman, December 9, 2010 - Letter Other LET-Letter 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-07-27T23:53:44Z   0 0 0900006480ddf992
FDA-2010-P-0176-0033 FDA None FDA-2010-P-0176 FDA/Office for Policy to Goodwin Proctor LLP, April 28, 2011 - Letter Other LET-Letter 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-08-11T03:14:55Z   0 0 0900006480de919c
FDA-2010-P-0176-0032 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) to FDA/CDRH Ombudsman, April 25, 2011 - Letter Other M-Memorandum 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-08-11T04:45:57Z   0 0 0900006480de919b
FDA-2010-P-0176-0028 FDA None FDA-2010-P-0176 FDA/Office for Policy to Staff Attorneys re Separation of Functions, February 3, 2011 - Memorandum Other M-Memorandum 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-08-11T04:44:11Z   0 0 0900006480bec5e9
FDA-2010-P-0176-0018 FDA None FDA-2010-P-0176 Exhibit D - "PMA Amendment 14 - January 14, 2010" - [Ethicon Endo-Surgery, Inc. - Petition for Reconsideration] Supporting & Related Material PRC-Petition for Reconsideration (Supporting and Related Material) 2011-05-24T04:00:00Z 2011 5     2011-05-24T23:05:39Z   0 0 0900006480aca0cc
FDA-2010-P-0176-0029 FDA None FDA-2010-P-0176 FDA/Office for Policy to Staff Attorneys re Separation of Functions, February 17, 2011 - Memorandum Other M-Memorandum 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2011-05-24T23:17:35Z   0 0 0900006480de7dc6
FDA-2010-P-0176-0035 FDA None FDA-2010-P-0176 Ethicon Endo-Surgery, Inc., (Goodwin Procter LLP) Response to FDA/CDRH Ombudsman, May 19, 2011 - Letter Other LET-Letter 2011-05-24T04:00:00Z 2011 5 2011-05-24T04:00:00Z   2013-07-27T23:53:43Z   0 0 0900006480dcf706
FDA-2010-P-0176-0007 FDA None FDA-2010-P-0176 Edwin Dutra to the Division of Dockets Management - Electronic Letter Other ELET-Electronic Letter 2011-04-06T04:00:00Z 2011 4 2011-03-21T04:00:00Z 2011-03-22T03:59:59Z 2013-07-27T23:48:35Z   0 0 0900006480c122e0
FDA-2010-P-0176-0003 FDA None FDA-2010-P-0176 SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s, Petition for Review of FDA's Denial of Premarket Approval Notice N-Notice 2011-03-21T04:00:00Z 2011 3 2011-03-21T04:00:00Z 2011-03-22T03:59:59Z 2011-11-28T15:22:00Z 2011-06520 0 0 0900006480c0c788
FDA-2010-P-0176-0004 FDA None FDA-2010-P-0176 Reference 1 - FDA/CDRH to Ethicon Endo-Surgery, Incorporated, October 26, 2010 - [SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s, Petition for Review of FDA's Denial of Premarket Approval] Supporting & Related Material N-Notice (Supporting and Related Material) 2011-03-21T04:00:00Z 2011 3     2011-04-22T15:45:34Z   0 0 0900006480c0c71d
FDA-2010-P-0176-0005 FDA None FDA-2010-P-0176 Reference 2 - "Charter Amendment Medical Devices Advisory Committee" - [SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s, Petition for Review of FDA's Denial of Premarket Approval] Supporting & Related Material N-Notice (Supporting and Related Material) 2011-03-21T04:00:00Z 2011 3     2011-04-22T15:46:10Z   0 0 0900006480c0c906
FDA-2010-P-0176-0006 FDA None FDA-2010-P-0176 Reference 3 - "Resolving Scientific Disputes Concerning The Regulation of Medical Devices, A Guide to use of the Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA, July 2, 2001" - [SEDASYS Computer-Assisted Personalized Sedation System; Ethicon Endo-Surgery, Inc.'s, Petition for Review of FDA's Denial of Premarket Approval] Supporting & Related Material N-Notice (Supporting and Related Material) 2011-03-21T04:00:00Z 2011 3     2011-04-22T15:47:52Z   0 0 0900006480c0c90b
FDA-2010-P-0176-0001 FDA None FDA-2010-P-0176 FDA/CDRH to Ethicon Endo-Surgery, Inc. - Denial of Application Other ADV-Denial of Application 2011-03-01T05:00:00Z 2011 3 2011-03-01T05:00:00Z   2013-08-11T03:13:23Z   0 0 0900006480bfbf2e

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CREATE TABLE documents (
    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
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
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;