|
Device | CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P860057 |
Supplement Number | S031 |
Date Received | 11/14/2005 |
Decision Date | 12/06/2005 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF AN INSPECTION FOR THE 3.8 OZ JAR USED TO PACKAGE THE BIOPROSTHETIC HEART VALVES. |