|
Device | ATS 3F AORTIC BIOPROSTHESIS |
Generic Name | heart-valve, non-allograft tissue |
Applicant | MEDTRONIC Inc. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS, MN 55432 |
PMA Number | P060025 |
Supplement Number | S007 |
Date Received | 09/17/2010 |
Decision Date | 10/15/2010 |
Withdrawal Date
|
10/26/2016 |
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 ADDITIONAL SUPPLIERS OF EQUINE TISSUE. |