|
Device | HANCOCK MODIFIED ORIFICE PORCINE BIOPROSTHETIC HEART VALVE |
Generic Name | heart-valve, non-allograft tissue |
Applicant | MEDTRONIC HEART VALVES 1851 EAST DEERE AVE. SANTA ANA, CA 92705 |
PMA Number | P790007 |
Supplement Number | S014 |
Date Received | 04/06/1998 |
Decision Date | 08/20/1998 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternate polyester for use in the sewing ring ofthe three heart valves. |