PMA P100022S022
- Device
- Zilver PTX Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S022
- Product code
- NIU
- Decision date
- 2017-05-02
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Approval for the extension of the shelf life of the Zilver PTX Drug-Eluting Peripheral Stent to 24 months.
Current openFDA PMA Record#
- Device
- Zilver PTX Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S022
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2017-05-02
- Decision code
- APPR
- Date received
- 2017-03-03
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the extension of the shelf life of the Zilver PTX Drug-Eluting Peripheral Stent to 24 months.