|
Device | Pathway Clinical Trial Cohort |
Generic Name | Aspiration therapy system |
Applicant | ASPIRE BARIATRICS INC 3200 HORIZON DRIVE SUITE 100 King of Prussia, PA 19406 |
PMA Number | P150024 |
Supplement Number | S016 |
Date Received | 10/29/2019 |
Decision Date | 04/24/2020 |
Withdrawal Date
|
04/20/2022 |
Product Code |
OYF |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval including the ODE Lead PMA Post-Approval Study - Extended Follow-up of the Premarket Cohort (PATHWAY Clinical Trial) has been fulfilled. |