Approval of the revised protocol with modifications including use of local labs for blood work, changes to the minimum and maximum number of patients enrolled per site, and a revised study timeline for the post-approval study (pas) protocol.
| Device | AspireAssist |
| Classification Name | Aspiration Therapy System |
| Generic Name | Aspiration Therapy System |
| Applicant | ASPIRE BARIATRICS INC |
| Date Received | 2018-05-01 |
| Decision Date | 2019-01-15 |
| PMA | P150024 |
| Supplement | S010 |
| Product Code | OYF |
| Advisory Committee | Gastroenterology/Urology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ASPIRE BARIATRICS INC 3200 Horizon Drive suite 100 king Of Prussia, PA 19406 |
Supplemental Filings
| 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) |
NIH GUDID Devices