|
Device | Avalus Ultra Bioprosthesis |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic Inc. 1851 E. Deere Avenue Santa Ana, CA 92705 |
PMA Number | P170006 |
Supplement Number | S025 |
Date Received | 09/01/2023 |
Decision Date | 01/31/2024 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for design modifications to the Avalus Bioprosthesis device including the addition of a radiopaque marker and changes to the stent base design and sewing ring. The device, as modified, will be marketed under the trade name Avalus Ultra Bioprosthesis. |