PMA P100022S038
- Device
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S038
- Product code
- NIU
- Decision date
- 2021-11-02
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Approval for the addition of the US ZILVER PTX POST-APPROVAL STUDY 2 (PAS 2) results to the Instructions for Use
Current openFDA PMA Record#
- Device
- Zilver® PTX® Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S038
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2021-11-02
- Decision code
- APPR
- Date received
- 2021-08-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for the addition of the US ZILVER PTX POST-APPROVAL STUDY 2 (PAS 2) results to the Instructions for Use