|
Device | CARPENTIER-EDWARDS PERIMOUNT BIOPROSTHESIS HEART VALVE |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P860057 |
Supplement Number | S063 |
Date Received | 12/07/2009 |
Decision Date | 03/25/2010 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AS EDWARDS LIFESCIENCES (SINGAPORE), FOR STERILIZATION AND FINAL PACKAGING PROCESSES. |