|
Device | Epic Plus and Epic Plus Supra |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P040021 |
Supplement Number | S056 |
Date Received | 11/17/2023 |
Decision Date | 01/23/2024 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for a modification to the stainless steel material used for the annular and post wire components of the Epic Plus and Epic Plus Supra tissue heart valves |