|
Device | CARPENTIER-SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650 |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P010041 |
Supplement Number | S006 |
Date Received | 01/31/2005 |
Decision Date | 02/28/2005 |
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 ADDITION OF AN ADDITIONAL SEMI-AUTOMATIC TORQUE MACHINE AND ASSOCIATED TOOLING. |
Post-Approval Study | Show Report Schedule and Study Progress |