Approval to modify the directions for use to add cautionary statements regarding how the needle is to be inserted into the access port septum to prevent damage to the access port.
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 | 2010-09-16 |
Decision Date | 2010-10-08 |
PMA | P000008 |
Supplement | S020 |
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 | Special (immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
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