|
Device | CARPENTIER-EDWARDS PORCINE AORTIC 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 | S055 |
Date Received | 11/28/2012 |
Decision Date | 02/28/2013 |
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 TO USE AN ALTERNATE PROCESS MANUFACTURING AID TO DISPENSE GLUTARALDEHYDE. |