|
Device | CARPENTIER EDWARDS BIOPROSTHESIS |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P870056 |
Supplement Number | S012 |
Date Received | 10/04/1999 |
Decision Date | 10/22/1999 |
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 proposed a change in the quality control tests used to declare sterility of finished bioprosthetic heart valves. The change will allow for parametric release following terminal liquid sterilization in accordance with Documentation and Release Criteria for Liquid Chemical Sterilization Process. |