|
Device | 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 | S011 |
Date Received | 03/05/2013 |
Decision Date | 04/02/2013 |
Withdrawal Date
|
10/26/2016 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REVISIONS TO THE LABELING REGARDING THE IMPLANTATION TECHNIQUE FOR THE BIOPROSTHESIS. |