PMA P100022S039
- Device
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- Product code
- NIU
- Decision date
- 2022-05-13
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Approval for a site change of an Active Pharmaceutical Ingredient (API) supplier.
Current openFDA PMA Record#
- Device
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S039
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2022-05-13
- Decision code
- APPR
- Date received
- 2021-09-30
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a site change of an Active Pharmaceutical Ingredient (API) supplier.