PMA P050017S018
- Device
- Zilver Vascular Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S018
- Product code
- NIO
- Decision date
- 2020-02-07
- Generic name
- STENT, ILIAC
- Approval order statement
- Change to the delivery system tip manufacturing process.
Current openFDA PMA Record#
- Device
- Zilver Vascular Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S018
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2020-02-07
- Decision code
- OK30
- Date received
- 2020-01-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the delivery system tip manufacturing process.