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 aspireassist® is intended to assist in weight reduction of obese patients. It is indicated for use in adults aged 22 or older with a body mass index (bmi) of 35. 0-55. 0 kg/m2 who have failed to achieve and maintain weight loss with non-surgical weight loss therapy. The aspireassist is intended for a long-term duration of use in conjunction with lifestyle therapy and continuous medical monitoring.
| Device | AspireAssist |
| Classification Name | Aspiration Therapy System |
| Generic Name | Aspiration Therapy System |
| Applicant | ASPIRE BARIATRICS INC |
| Date Received | 2015-07-08 |
| Decision Date | 2016-06-14 |
| Notice Date | 2016-06-14 |
| PMA | P150024 |
| Supplement | S |
| Product Code | OYF |
| Docket Number | 16m-1754 |
| Advisory Committee | Gastroenterology/Urology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ASPIRE BARIATRICS INC 3200 Horizon Drive suite 100 king Of Prussia, PA 19406 |
| 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 |
|---|---|---|
| P150024 | Original Filing | |
| S016 | 2019-10-29 | Normal 180 Day Track No User Fee |
| S015 | ||
| S014 | ||
| S013 | ||
| S012 | 2018-09-25 | Special (immediate Track) |
| S011 | 2018-05-22 | Special (immediate Track) |
| S010 | 2018-05-01 | Normal 180 Day Track No User Fee |
| S009 | 2018-02-07 | Special (immediate Track) |
| S008 | 2018-01-19 | Normal 180 Day Track |
| S007 | ||
| S006 | 2017-03-27 | Real-time Process |
| S005 | 2016-10-17 | Normal 180 Day Track No User Fee |
| S004 | 2016-08-16 | Real-time Process |
| S003 | 2016-08-15 | Special (immediate Track) |
| S002 | ||
| S001 | 2016-07-29 | Special (immediate Track) |
| Device ID | PMA | Supp |
|---|---|---|
| 10857808005471 | P150024 | 000 |
| 10857808005044 | P150024 | 000 |
| 10857808005037 | P150024 | 000 |
| 10857808005020 | P150024 | 000 |
| 10857808005013 | P150024 | 000 |