This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of the post-approval study protocol.
| Device | ORBERA INTRAGASTRIC BALLOON SYSTEM |
| Classification Name | Implant, Intragastric For Morbid Obesity |
| Generic Name | Implant, Intragastric For Morbid Obesity |
| Applicant | APOLLO ENDOSURGERY INC |
| Date Received | 2015-09-03 |
| Decision Date | 2016-02-26 |
| PMA | P140008 |
| Supplement | S002 |
| Product Code | LTI |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | APOLLO ENDOSURGERY INC 1120 S Capital Of Tx Hwy bldg 1, Ste 300 austin, TX 78746-0000 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P140008 | Original Filing | |
| S024 | 2022-07-11 | Real-time Process |
| S023 | 2021-12-06 | 30-day Notice |
| S022 | 2021-05-19 | Real-time Process |
| S021 | 2020-09-18 | Special (immediate Track) |
| S020 | ||
| S019 | ||
| S018 | 2019-06-24 | 30-day Notice |
| S017 | 2019-03-04 | Special (immediate Track) |
| S016 | ||
| S015 | ||
| S014 | 2018-10-02 | Normal 180 Day Track No User Fee |
| S013 | 2018-06-12 | Normal 180 Day Track No User Fee |
| S012 | 2018-05-01 | Special (immediate Track) |
| S011 | 2017-12-27 | Special (immediate Track) |
| S010 | ||
| S009 | ||
| S008 | 2017-11-06 | 135 Review Track For 30-day Notice |
| S007 | 2017-05-25 | Normal 180 Day Track No User Fee |
| S006 | 2017-05-08 | Special (immediate Track) |
| S005 | 2017-04-12 | 30-day Notice |
| S004 | ||
| S003 | 2015-09-18 | Normal 180 Day Track No User Fee |
| S002 | 2015-09-03 | Normal 180 Day Track No User Fee |
| S001 | 2015-08-31 | 135 Review Track For 30-day Notice |