|
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 | S025 |
Date Received | 06/01/2017 |
Decision Date | 06/15/2017 |
Product Code |
NIU |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for minor modifications to the female luer lock adapter component. |