PMA P100022
- Device
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S040
- Product code
- NIU
- Decision date
- 2026-03-25
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- an approval for a change in the annual monitoring stability study sampling plan
Current openFDA PMA Record#
- Device
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S045
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2026-03-25
- Decision code
- OK30
- Date received
- 2026-03-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an approval for a change in the annual monitoring stability study sampling plan