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 | 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 | S064 |
Date Received | 12/14/2009 |
Decision Date | 01/12/2010 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF TWO EXISTING MODELS TO THOSE ALREADY APPROVED FOR THE CHANGI, SINGAPORE FACILITY AND TO PERFORM A FINAL ASSEMBLY STEP AT THIS FACILITY IN ADDITION TO THE IRVINE AND HOWR FACILITIES. |
|
|