|
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 | S001 |
Date Received | 12/03/2012 |
Decision Date | 06/03/2013 |
Product Code |
NIU |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A PRODUCT LINE EXTENSION FOR THE ZILVER PTX DRUG-ELUTING PERIPHERAL STENT. THIS LINE EXTENSION INCLUDES ADDITIONAL STENT LENGTHS OF 100MM AND 120MM. |