|
Device | AspireAssist |
Generic Name | Aspiration therapy system |
Applicant | ASPIRE BARIATRICS INC 3200 HORIZON DRIVE SUITE 100 King of Prussia, PA 19406 |
PMA Number | P150024 |
Supplement Number | S005 |
Date Received | 10/17/2016 |
Decision Date | 12/15/2016 |
Withdrawal Date
|
04/20/2022 |
Product Code |
OYF |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the revised protocol for the post-approval study (PAS) protocol. |