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 for labeling changes have been requested by the office of surveillance and biometrics, signal management program as a result of a safety signal with fluid filled gastric balloons.
| 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 | 2017-05-08 |
| Decision Date | 2017-06-06 |
| PMA | P140008 |
| Supplement | S006 |
| Product Code | LTI |
| 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 | 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 |