|
Device | Edwards INTUITY Elite Valve |
Generic Name | heart-valve, non-allograft tissue |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P150036 |
Supplement Number | S056 |
Date Received | 08/11/2021 |
Decision Date | 09/08/2021 |
Product Code |
LWR |
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 Reduction of the number of in-process glutaraldehyde solution change-outs for surgical pericardial heart valves. |