|
Device | CARPENTIER-EDWARDS(R) DURAFLEX(TM) BIOPROSTHESIS, MODELS 6625-LP AND 6625 ESR-LP |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P870077 |
Supplement Number | S003 |
Date Received | 04/17/1996 |
Decision Date | 10/17/1996 |
Withdrawal Date
|
01/28/2022 |
Product Code |
DYE |
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 MODIFICATION OF YOUR STERILIZATION PROCESS TO REMOVE AN ASEPTIC STERILANT-TO-STORAGE TRANSFER PROCESS AND REPLACE IT WITH A TERMINAL STEERILIZATION PROCESS |
Post-Approval Study | Show Report Schedule and Study Progress |