Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | Avalus Bioprosthesis, Model 400 |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic Inc. 1851 E. Deere Avenue Santa Ana, CA 92705 |
PMA Number | P170006 |
Supplement Number | S005 |
Date Received | 11/22/2017 |
Decision Date | 12/15/2017 |
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 Extension to the in-process tissue coupon storage time. |
|
|