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 | MOSAIC PORCINE BIOPROSTHETIC HEART VALVE |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Medtronic, Inc. 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P990064 |
Supplement Number | S057 |
Date Received | 07/21/2014 |
Decision Date | 02/25/2015 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE STENT MATERIAL FROM ACETALHOMOPOLYMER (AHP) TO POLYETHERETHERKETONE, PEEK I5R (PEEK) FOR THE DEVICES. |
|
|