|
Device | CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P010041 |
Supplement Number | S011 |
Date Received | 08/30/2006 |
Decision Date | 01/29/2007 |
Withdrawal Date
|
01/28/2022 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL SUPPLIER OF TWIST POLYTETRAFLUOROETH-YLENE (PTFE) SEWING THREAD. |
Post-Approval Study | Show Report Schedule and Study Progress |