PMA P100022S018
- Device
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S018
- Product code
- NIU
- Decision date
- 2016-07-01
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Alternate resin for several delivery system components.
Current openFDA PMA Record#
- Device
- ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S018
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2016-07-01
- Decision code
- OK30
- Date received
- 2016-06-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate resin for several delivery system components.