Approval of the following changes to the post-approval study for the device: revisions reflecting alignment of protocol terminology with terms used in the electronic datamanagement system and points of clarification based on irb input.
| Device | LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM |
| Classification Name | Implant, Intragastric For Morbid Obesity |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | ReShape Lifesciences, Inc. |
| Date Received | 2015-07-06 |
| Decision Date | 2016-03-03 |
| PMA | P000008 |
| Supplement | S034 |
| Product Code | LTI |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ReShape Lifesciences, Inc. 100 Calle Amanecer san Clemente, CA 92672 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000008 | | Original Filing |
| S047 |
2019-07-24 |
Real-time Process |
| S046 |
2018-12-19 |
30-day Notice |
| S045 |
2018-12-18 |
135 Review Track For 30-day Notice |
| S044 |
2018-09-24 |
30-day Notice |
| S043 |
2018-06-25 |
30-day Notice |
| S042 |
2018-01-16 |
30-day Notice |
| S041 |
2017-12-15 |
30-day Notice |
| S040 |
2017-12-15 |
30-day Notice |
| S039 |
2017-07-05 |
Normal 180 Day Track No User Fee |
| S038 |
2017-02-15 |
30-day Notice |
| S037 |
2016-01-29 |
Normal 180 Day Track No User Fee |
| S036 |
2015-12-21 |
Normal 180 Day Track No User Fee |
| S035 |
2015-10-26 |
Normal 180 Day Track No User Fee |
| S034 |
2015-07-06 |
Normal 180 Day Track No User Fee |
| S033 |
2015-01-29 |
Normal 180 Day Track No User Fee |
| S032 |
2014-10-06 |
Special (immediate Track) |
| S031 |
2013-04-18 |
Normal 180 Day Track No User Fee |
| S030 |
2013-03-05 |
30-day Notice |
| S029 |
2012-09-13 |
Normal 180 Day Track No User Fee |
| S028 |
2012-06-01 |
Normal 180 Day Track |
| S027 |
2012-02-29 |
Normal 180 Day Track |
| S026 |
2011-10-11 |
Real-time Process |
| S025 | | |
| S024 |
2011-07-14 |
Special (immediate Track) |
| S023 |
2011-03-18 |
Normal 180 Day Track No User Fee |
| S022 |
2011-03-18 |
Normal 180 Day Track No User Fee |
| S021 |
2010-10-12 |
30-day Notice |
| S020 |
2010-09-16 |
Special (immediate Track) |
| S019 |
2010-07-02 |
Normal 180 Day Track No User Fee |
| S018 |
2010-05-21 |
Special (immediate Track) |
| S017 |
2010-04-27 |
Panel Track |
| S016 | | |
| S015 | | |
| S014 |
2008-12-18 |
Special (immediate Track) |
| S013 |
2008-04-07 |
135 Review Track For 30-day Notice |
| S012 |
2008-02-28 |
Normal 180 Day Track |
| S011 | | |
| S010 |
2006-10-03 |
Normal 180 Day Track No User Fee |
| S009 |
2005-10-26 |
Normal 180 Day Track |
| S008 |
2005-08-09 |
Normal 180 Day Track |
| S007 | | |
| S006 |
2003-06-05 |
Normal 180 Day Track |
| S005 |
2002-11-21 |
Normal 180 Day Track |
| S004 |
2002-03-14 |
Normal 180 Day Track |
| S003 |
2002-03-13 |
Normal 180 Day Track |
| S002 |
2002-01-24 |
Normal 180 Day Track |
| S001 |
2002-01-11 |
Normal 180 Day Track |
NIH GUDID Devices