|
Device | ATS 3F AORTIC BIOPROSTHESIS MODEL 1000 |
Generic Name | heart-valve, non-allograft tissue |
Applicant | MEDTRONIC Inc. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS, MN 55432 |
PMA Number | P060025 |
Supplement Number | S005 |
Date Received | 05/14/2010 |
Decision Date | 07/13/2010 |
Withdrawal Date
|
10/26/2016 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL PROTOCOL. |