Approval for lap-band adjustable gastric banding system. The lap-band system is indicated for weight reduction for patients with obesity, with a body mass index (bmi) of at least 40 kg/m2 or a bmi of at least 30 kg/ m2 with one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.
| Device | LAP-BAND |
| Classification Name | Implant, Intragastric For Morbid Obesity |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | ReShape Lifesciences, Inc. |
| Date Received | 2010-04-27 |
| Decision Date | 2011-02-16 |
| Notice Date | 2012-09-26 |
| PMA | P000008 |
| Supplement | S017 |
| Product Code | LTI |
| Docket Number | 12M-1013 |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Panel 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 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
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