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withdrawn,object_id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