|
Device | CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS MODELS 6625LP AND 6625 LP-ESR |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P870077 |
Supplement Number | S008 |
Date Received | 10/09/1998 |
Decision Date | 10/26/1998 |
Withdrawal Date
|
01/28/2022 |
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 The 30-day notice requested a change in the incubation period for the Test of Sterility (of both the sterilant solution and of sterilized products) to reduce the total time required to manufacture the bioprostheses. |
Post-Approval Study | Show Report Schedule and Study Progress |