PMA P100022S030
- Device
- Zilver PTX Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S030
- Product code
- NIU
- Decision date
- 2018-12-20
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Approval to update the labeling to include post-approval study clinical data.
Current openFDA PMA Record#
- Device
- Zilver PTX Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S030
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2018-12-20
- Decision code
- APPR
- Date received
- 2018-10-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval to update the labeling to include post-approval study clinical data.