PMA P050017S023
- Device
- Zilver® Vascular Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S023
- Product code
- NIO
- Decision date
- 2024-05-14
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- updating the IPCD utilized in annual requalification of Steris Tullamore Lines 8 and 9
Current openFDA PMA Record#
- Device
- Zilver® Vascular Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S023
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2024-05-14
- Decision code
- OK30
- Date received
- 2024-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- updating the IPCD utilized in annual requalification of Steris Tullamore Lines 8 and 9