PMA P100022S021
- Device
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S021
- Product code
- NIU
- Decision date
- 2016-12-16
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Approval for additional quality control inspections.
Current openFDA PMA Record#
- Device
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S021
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2016-12-16
- Decision code
- APPR
- Date received
- 2016-11-18
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for additional quality control inspections.