|
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 | S010 |
Date Received | 05/01/2018 |
Decision Date | 01/15/2019 |
Withdrawal Date
|
04/20/2022 |
Product Code |
OYF |
Advisory Committee |
Gastroenterology/Urology |
Clinical Trials | NCT01766037
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |