|
Device | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT |
Generic Name | Stent, superficial femoral artery, drug-eluting |
Applicant | Cook Ireland, Ltd. O'Halloran Road National Technology Park Limerick |
PMA Number | P100022 |
Supplement Number | S009 |
Date Received | 09/20/2013 |
Decision Date | 10/16/2013 |
Product Code |
NIU |
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 MODIFY THE HANDLE ASSEMBLY AND PUSHER CANNULA/HOLDING BUSHING BONDING PROCESSES FOR THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENTS. |