|
Device | EDWARDS INTUITY Elite Aortic Valve |
Generic Name | heart-valve, non-allograft tissue |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P150036 |
Supplement Number | S049 |
Date Received | 02/07/2020 |
Decision Date | 03/05/2020 |
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 Replacement of the Preliminary Packaging Optical Characterization Verification (OCV) system with the Optical Characterization Recognition Printing (OCRP) system for non-RESILIA valves and removal of the OCV system for RESILIA valves. |