This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the reshape integrated dual balloon system. The reshape integrated dual balloon system is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a body mass index (bmi) of 30 40 kg/m2 and one or more obesity-related comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
| Device | RESHAPE INTEGRATED DUAL BALLOON SYSTEM |
| Classification Name | Implant, Intragastric For Morbid Obesity |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | Appollo Endosurgery |
| Date Received | 2014-07-01 |
| Decision Date | 2015-07-28 |
| Notice Date | 2015-07-29 |
| PMA | P140012 |
| Supplement | S |
| Product Code | LTI |
| Docket Number | 15M-2740 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Appollo Endosurgery 1120 S Capital Of Tx Hwy bldg 1, Ste 300 austin, TX 78746 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140012 | Original Filing | |
| S013 | 2018-05-02 | Special (immediate Track) |
| S012 | 2018-02-26 | Normal 180 Day Track No User Fee |
| S011 | 2017-09-27 | 30-day Notice |
| S010 | 2017-04-28 | Normal 180 Day Track No User Fee |
| S009 | 2017-03-22 | Special (immediate Track) |
| S008 | 2017-01-23 | 30-day Notice |
| S007 | 2016-12-19 | 30-day Notice |
| S006 | 2016-12-07 | 30-day Notice |
| S005 | 2016-09-26 | 30-day Notice |
| S004 | 2015-12-01 | 30-day Notice |
| S003 | 2015-11-18 | Real-time Process |
| S002 | 2015-09-28 | Normal 180 Day Track |
| S001 | 2015-08-26 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| B001RSM9001 | P140012 | 000 |
| B001RSM2101 | P140012 | 000 |
| B001RSM1011 | P140012 | 000 |
| B001RSM1101 | P140012 | 002 |