|
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 | S028 |
Date Received | 08/01/2018 |
Decision Date | 08/29/2018 |
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 Addition of a delivery system component specification and changes to a supplier's extrusion line. |