|
Device | Edwards Intuity Elite Valve System |
Generic Name | heart-valve, non-allograft tissue |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P150036 |
Supplement Number | S045 |
Date Received | 11/01/2019 |
Decision Date | 11/24/2019 |
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 to down classify gowning room 129 from ISO Class 7 to ISO Class 8 at the Irvine facility |