PMA P100022S040
- Device
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S040
- Product code
- NIU
- Decision date
- 2022-02-02
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Approval for an additional active pharmaceutical ingredient supplier.
Current openFDA PMA Record#
- Device
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S040
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2022-02-02
- Decision code
- APPR
- Date received
- 2021-11-04
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional active pharmaceutical ingredient supplier.