PMA P100022S042
- Device
- Zilver® PTX® Peripheral Drug- Eluting Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S042
- Product code
- NIU
- Decision date
- 2023-09-22
- Classification
- Cardiovascular
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Changes to adhesives used in stent delivery systems.
Current openFDA PMA Record#
- Device
- Zilver® PTX® Peripheral Drug- Eluting Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S042
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2023-09-22
- Decision code
- OK30
- Date received
- 2023-08-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to adhesives used in stent delivery systems.