documents
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
37 rows where agency_id = "FDA" and docket_id = "FDA-2009-M-0101" sorted by posted_date descending
This data as json, CSV (advanced)
Suggested facets: subtype, posted_date, posted_month, comment_start_date, open_for_comment, withdrawn, posted_date (date), comment_start_date (date), comment_end_date (date), last_modified (date)
document_type 3
- Other 20
- Supporting & Related Material 16
- Notice 1
agency_id 1
- FDA · 37 ✖
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 | None 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 |
Advanced export
JSON shape: default, array, newline-delimited, object
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;