PMA P200023S002
- Device
- Zilver Vena Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S002
- Product code
- QAN
- Decision date
- 2021-10-26
- Generic name
- Stent, iliac vein
- Approval order statement
- Adding a manufacturing site for delivery system tips and process changes for inner catheters.
Current openFDA PMA Record#
- Device
- Zilver Vena Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S002
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2021-10-26
- Decision code
- OK30
- Date received
- 2021-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding a manufacturing site for delivery system tips and process changes for inner catheters.