Approval for the following modifications to the lap-band adustable gastric banding (lagb) system: 1) introduction of a redesigned access port (access port ii); 2) replace the calibration tube (calibration tube i) currently provided in the lagb) system with a redesigned calibration tube (calibration tube ii); and 3) introduction of 2" access port needles to be sold as an accessory item. In addition to being sold as components of the lagb system, both the access port ii and the calibration tube ii will be sold as separate accessories.
| Device | BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM |
| Classification Name | Implant, Intragastric For Morbid Obesity |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | ReShape Lifesciences, Inc. |
| Date Received | 2002-01-24 |
| Decision Date | 2002-08-01 |
| PMA | P000008 |
| Supplement | S002 |
| 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 |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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