|
Device | Trifecta™ Valve with Glide Technology™ |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P100029 |
Supplement Number | S048 |
Date Received | 10/20/2022 |
Decision Date | 12/06/2022 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implementation of a continuous airflow monitoring system. |