PMA P100022S035
- Device
- Zilver PTX Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S035
- Product code
- NIU
- Decision date
- 2020-05-15
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Approval order statement
- Changes to the process challenge devices used for routine sterilization processing and routine sterilization requalification.
Current openFDA PMA Record#
- Device
- Zilver PTX Drug-Eluting Peripheral Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P100022
- Supplement
- S035
- Product code
- NIU
- Generic name
- Stent, superficial femoral artery, drug-eluting
- Decision date
- 2020-05-15
- Decision code
- OK30
- Date received
- 2020-04-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the process challenge devices used for routine sterilization processing and routine sterilization requalification.