|
Device | Avalus Bioprosthesis and 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 | S033 |
Date Received | 04/10/2024 |
Decision Date | 04/22/2024 |
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 relocation and revalidation of certain front-end manufacturing processes to an existing cleanroom to consolidate all front-end manufacturing processes in one congregated space to improve manufacturing process flow |