|
Device | ASCENDRA + DELIVERY SYSTEM |
Generic Name | Aortic valve, prosthesis, percutaneously delivered |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P130009 |
Supplement Number | S039 |
Date Received | 07/24/2015 |
Decision Date | 08/07/2015 |
Product Code |
NPT |
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 EXTEND THE APPLICATION AREA OF THE CURRENTLY APPROVED ADHESIVE AT THE Y-CONNECTOR TO GUIDEWIRE SHAFT BOND OF THE ASCENDRA+ DELIVERY SYSTEM AND ADD A QUALITY INSPECTION OF THE ADHESIVE AT BOTH THE Y-CONNECTOR TO GUIDEWIRE SHAFT AND Y-CONNECTOR TO BALLOON SHAFT BOND SITES. |