PMA P100022S041
- Device
- Zilver® PTX® Peripheral Drug-Eluting Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S041
- Product code
- NIU
- Decision date
- 2023-03-16
- Classification
- Cardiovascular
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Alternative supplier of an adhesive used in the manufacture of the delivery system.
Current openFDA PMA Record#
- Device
- Zilver® PTX® Peripheral Drug-Eluting Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S041
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2023-03-16
- Decision code
- OK30
- Date received
- 2023-02-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative supplier of an adhesive used in the manufacture of the delivery system.