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withdrawn,object_id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-2009-M-0101-0124,FDA,FDA-2009-M-0101,Letter from CDRH to Orthopedic Surgical Manufacturers Association (OSMA),Other,Letter(s),2017-06-26T04:00:00Z,2017,6,2017-06-26T04:00:00Z,,2017-06-26T16:48:39Z,,0,0,0900006482796fd3
FDA-2009-M-0101-0123,FDA,FDA-2009-M-0101,Petition Denial letter to Philips Healthcare,Other,Denial of Petition,2015-01-29T05:00:00Z,2015,1,2015-01-29T05:00:00Z,,2015-01-29T12:39:08Z,,0,0,09000064819e52e0
FDA-2009-M-0101-0122,FDA,FDA-2009-M-0101,"FDA/CDRH Response Letter to Osypka Medical, Inc., September 16, 2014 re Reclassification Petition FDA-2009-M-0101-0172",Other,Letter(s),2014-09-19T04:00:00Z,2014,9,2014-09-19T04:00:00Z,,2014-09-19T13:17:04Z,,0,0,090000648187ee54
FDA-2009-M-0101-0121,FDA,FDA-2009-M-0101,"FDA/CDRH Response Letter to Osypka Medical, Inc., September 16, 2014 re Reclassification Petition FDA-2009-M-0101-0171",Other,Letter(s),2014-09-19T04:00:00Z,2014,9,2014-09-19T04:00:00Z,,2014-09-19T13:12:32Z,,0,0,090000648187ee53
FDA-2009-M-0101-0120,FDA,FDA-2009-M-0101,Pediatric Orthopaedic Society of North America (POSNA) and Scoliosis Research Sciety (SRS) - Comment re FDA-2009-M-0101-DRAFT-0034,Other,Change in Classification Petition,2013-05-24T04:00:00Z,2013,5,2013-05-24T04:00:00Z,,2013-05-24T20:23:25Z,,0,0,0900006480b39d1f
FDA-2009-M-0101-0113,FDA,FDA-2009-M-0101,"FDA/CDRH Response Letter to Philips Healthcare December 27, 2012 - Letter",Other,Letter(s),2013-03-08T05:00:00Z,2013,3,2013-03-08T05:00:00Z,,2024-11-07T22:52:52Z,,1,0,090000648121feaa
FDA-2009-M-0101-0111,FDA,FDA-2009-M-0101,Leonhard Lang - Petition for Reclassification re FDA-2009-M-0101-0037,Other,Change in Classification Petition,2013-02-25T05:00:00Z,2013,2,2013-02-25T05:00:00Z,,2013-07-27T22:51:36Z,,0,0,0900006480a05bde
FDA-2009-M-0101-0091,FDA,FDA-2009-M-0101,"Jolife, AB (Hogan & Hartson, LLP) - Petition for Reclassification",Other,Change in Classification Petition,2013-01-29T05:00:00Z,2013,1,2013-01-29T05:00:00Z,,2013-07-27T22:52:24Z,,0,0,0900006480a0dd5a
FDA-2009-M-0101-0095,FDA,FDA-2009-M-0101,Biomet Manufacturing Corp. - Petition for Reclassification,Other,Change in Classification Petition,2013-01-29T05:00:00Z,2013,1,2013-01-29T05:00:00Z,,2013-07-27T22:53:14Z,,0,0,0900006480a18bd1
FDA-2009-M-0101-0092,FDA,FDA-2009-M-0101,Michigan Instruments - Petition for Reclassification,Other,Change in Classification Petition,2013-01-29T05:00:00Z,2013,1,2013-01-29T05:00:00Z,,2013-07-27T22:52:24Z,,0,0,0900006480a0dd58
FDA-2009-M-0101-0096,FDA,FDA-2009-M-0101,Biomet Manufacturing Corporation - Petition for Reclassification Amendment re FDA-2009-M-0101-0095,Other,Amendment,2013-01-29T05:00:00Z,2013,1,2013-01-29T05:00:00Z,,2013-01-30T02:40:34Z,,0,0,0900006480a2c7f0
FDA-2009-M-0101-0056,FDA,FDA-2009-M-0101,Philips Healthcare to FDA/CDRH - Letter re FDA-2009-M-0101-0044,Other,Letter(s),2012-07-10T04:00:00Z,2012,7,,,2012-07-10T15:46:32Z,,0,0,0900006481083a0a
FDA-2009-M-0101-0051,FDA,FDA-2009-M-0101,Attachment 1- re Diapulse Corporation of America - Information,Supporting & Related Material,Information Collection Documentation,2012-07-08T04:00:00Z,2012,7,,,2012-07-08T14:47:25Z,,0,0,090000648107e66c
FDA-2009-M-0101-0047,FDA,FDA-2009-M-0101,Letter to Philips Healthcare,Other,Letter(s),2012-06-15T04:00:00Z,2012,6,2012-06-15T04:00:00Z,,2024-11-12T05:04:08Z,,1,0,090000648103c2f7
FDA-2009-M-0101-0048,FDA,FDA-2009-M-0101,American Academy of Orthopaedic Surgeons (AAOS) et al - (re Orthopedic Surgical Manufacturers Association (OSMA) - Petition for Reclassification) - Comment,Other,Change in Classification Petition,2012-06-15T04:00:00Z,2012,6,2012-06-15T04:00:00Z,,2012-06-15T20:05:45Z,,0,0,0900006480b73226
FDA-2009-M-0101-0046,FDA,FDA-2009-M-0101,Spire Biomedical Incorporated  - Petition for Reclassification re FDA-2009-M-0101-0027,Other,Change in Classification Petition,2012-06-15T04:00:00Z,2012,6,2012-06-15T04:00:00Z,,2013-07-27T22:54:41Z,,0,0,0900006480a241f2
FDA-2009-M-0101-0044,FDA,FDA-2009-M-0101,Philips Medical Systems Cardiac Care - Petition for Reclassification,Other,Change in Classification Petition,2012-04-09T04:00:00Z,2012,4,2012-04-09T04:00:00Z,,2012-04-09T22:40:24Z,,0,0,0900006480a05f81
FDA-2009-M-0101-0043,FDA,FDA-2009-M-0101,Philips Healthcare to FDA/CDRH - Letter,Other,Letter(s),2012-04-09T04:00:00Z,2012,4,2010-01-11T05:00:00Z,,2024-11-12T05:01:36Z,,1,0,0900006480fec285
FDA-2009-M-0101-0040,FDA,FDA-2009-M-0101,Philips Medical Systems Cardiac Care - Petition for Reclassification,Other,Change in Classification Petition,2011-12-12T05:00:00Z,2011,12,2011-12-12T05:00:00Z,,2013-07-28T00:10:31Z,,0,0,0900006480f80aac
FDA-2009-M-0101-0029,FDA,FDA-2009-M-0101,"Merit Medical Systems, Inc. - Information re FDA-2009-M-0101-DRAFT-0122 and 0043",Supporting & Related Material,Reference (external attachments),2011-12-12T05:00:00Z,2011,12,,,2011-12-12T19:22:58Z,,0,0,0900006480f80465
FDA-2009-M-0101-0033,FDA,FDA-2009-M-0101,"Appendix B - Cited Articles re Smiths Medical ASD, Inc. - Information FDA-2009-M-0101-DRAFT-0033",Supporting & Related Material,Reference (external attachments),2011-12-12T05:00:00Z,2011,12,,,2011-12-12T21:54:31Z,,0,0,0900006480f809f8
FDA-2009-M-0101-0037,FDA,FDA-2009-M-0101,Leonhard Lang - Petition for Reclassification re FDA-2009-M-0101-0111,Other,Change in Classification Petition,2011-12-12T05:00:00Z,2011,12,2011-12-12T05:00:00Z,,2013-08-11T01:44:59Z,,0,0,0900006480f80a51
FDA-2009-M-0101-0028,FDA,FDA-2009-M-0101,American Academy of Orthopaedic Surgeons (AAOS) - [(re Orthopedic Surgical Manufacturers Association (OSMA) - Petition for Reclassification) - Comment] - Background Material,Supporting & Related Material,Change in Classification Petition,2011-07-25T04:00:00Z,2011,7,,,2011-07-25T23:12:40Z,,0,0,0900006480eca49e
FDA-2009-M-0101-0027,FDA,FDA-2009-M-0101,Appendix IV - Copies of Reference Literature (Spire Biomedical Incorporated - Petition for Reclassification) re FDA-2009-M-0101-0046,Supporting & Related Material,Change in Classification Petition,2011-07-25T04:00:00Z,2011,7,,,2012-06-15T19:50:19Z,,0,0,0900006480b4686a
FDA-2009-M-0101-0023,FDA,FDA-2009-M-0101,"Bard Access Systems, Inc. - Information",Supporting & Related Material,Information Collection Documentation,2011-07-25T04:00:00Z,2011,7,,,2011-12-12T19:04:57Z,,0,0,0900006480b4683e
FDA-2009-M-0101-0026,FDA,FDA-2009-M-0101,"Zimmer, Inc. - Information re FDA-2009-M-0101-0094",Supporting & Related Material,Information Collection Documentation,2011-07-25T04:00:00Z,2011,7,,,2013-05-24T21:10:15Z,,0,0,0900006480a18ae7
FDA-2009-M-0101-0010,FDA,FDA-2009-M-0101,MECTA Corporation - Petition for Reclassification,Other,Change in Classification Petition,2010-01-11T05:00:00Z,2010,1,2010-01-11T05:00:00Z,,2013-07-27T23:04:05Z,,0,0,0900006480a7b55e
FDA-2009-M-0101-0011,FDA,FDA-2009-M-0101,"Appendix C ""SpECTrum Safety Information"" - [MECTA Corporation - Petition for Reclassification] re FDA-2009-M-0101-0010",Supporting & Related Material,CCP-Change in Classification Petition,2010-01-11T05:00:00Z,2010,1,,,2010-03-04T16:39:21Z,,0,0,0900006480a7b619
FDA-2009-M-0101-0008,FDA,FDA-2009-M-0101,"Reference 8  - ""Federal Register, March 24, 2003 (Volume 68, Number 56)"" - [Richard Abrams, M.D. and Conrad M. Swartz, Ph.D., M.D. (Somatics, LLC) - Information] re FDA-2009-M-0101-0007",Supporting & Related Material,INFO-Information (Supporting and Related Material),2010-01-11T05:00:00Z,2010,1,,,2010-01-11T18:33:04Z,,0,0,0900006480a0211c
FDA-2009-M-0101-0009,FDA,FDA-2009-M-0101,"Reference 16  Hoyert, Division of Vital Statistics, Maternal Mortality and Related Concepts re FDA-2009-M-0101-0007",Supporting & Related Material,INFO-Information (Supporting and Related Material),2010-01-11T05:00:00Z,2010,1,,,2013-05-08T21:12:11Z,,0,0,0900006480a02127
FDA-2009-M-0101-0012,FDA,FDA-2009-M-0101,"Appendix E - ""...Over Thirty-Five Years of Neuromodulation Innovations"" - [MECTA Corporation - Petition for Reclassification] re FDA-2009-M-0101-0010",Supporting & Related Material,CCP- Change in Certification Petition (Supporting and Related Material),2010-01-11T05:00:00Z,2010,1,,,2010-03-04T16:40:30Z,,0,0,0900006480a7b678
FDA-2009-M-0101-0005,FDA,FDA-2009-M-0101,"Updated Submission Forthcoming - [Gish Biomedical, Inc. - Information]",Supporting & Related Material,,2009-07-18T00:00:00Z,2009,7,,,2009-07-31T20:39:43Z,,0,1,09000064809f4cd2
FDA-2009-M-0101-0006,FDA,FDA-2009-M-0101,Bio Electronics Corporation - Information,Supporting & Related Material,,2009-07-18T00:00:00Z,2009,7,,,2009-07-30T18:00:17Z,,0,1,09000064809f4cd3
FDA-2009-M-0101-0003,FDA,FDA-2009-M-0101,The Female Health Company - Information,Supporting & Related Material,,2009-06-10T00:00:00Z,2009,6,,,2009-06-18T17:26:15Z,,0,1,09000064809a507b
FDA-2009-M-0101-0004,FDA,FDA-2009-M-0101,"TMJ Implants, Inc. - Information",Supporting & Related Material,,2009-06-10T00:00:00Z,2009,6,,,2009-06-18T17:27:42Z,,0,1,09000064809c6c0c
FDA-2009-M-0101-0002,FDA,FDA-2009-M-0101,GE Healthcare - Information,Supporting & Related Material,,2009-06-10T00:00:00Z,2009,6,,,2009-06-18T17:25:00Z,,0,1,0900006480991dbb
FDA-2009-M-0101-0001,FDA,FDA-2009-M-0101,Medical Devices; Order for Certain Class III Devices; Submission of Safety and Effectiveness Information,Notice,N-Notice,2009-04-09T04:00:00Z,2009,4,2009-04-09T04:00:00Z,2009-08-08T03:59:59Z,2013-05-10T01:05:57Z,E9-08022,0,0,090000648094bbd0