|
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 | S021 |
Date Received | 11/18/2016 |
Decision Date | 12/16/2016 |
Product Code |
NIU |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for additional quality control inspections. |