PMA P100022S029
- Device
- Zilver PTX Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S029
- Product code
- NIU
- Decision date
- 2018-08-23
- Classification
- Stent, Superficial Femoral Artery, Drug-eluting
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- modifications to raw material specifications, test methods, and frequency of testing
Current openFDA PMA Record#
- Device
- Zilver PTX Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S029
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2018-08-23
- Decision code
- OK30
- Date received
- 2018-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- modifications to raw material specifications, test methods, and frequency of testing