|
Device | Zilver® PTX® Peripheral Drug-Eluting 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 | S041 |
Date Received | 02/15/2023 |
Decision Date | 03/16/2023 |
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 | Yes |
Approval Order Statement Alternative supplier of an adhesive used in the manufacture of the delivery system. |