PMA P100022S028
- Device
- ZILVER PTX Drug-Eluting Peripheral Stent.
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S028
- Product code
- NIU
- Decision date
- 2018-08-29
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Addition of a delivery system component specification and changes to a supplier's extrusion line.
Current openFDA PMA Record#
- Device
- ZILVER PTX Drug-Eluting Peripheral Stent.
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S028
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2018-08-29
- Decision code
- OK30
- Date received
- 2018-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a delivery system component specification and changes to a supplier's extrusion line.