PMA P200023
- Device
- Zilver® Vena® Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S002
- Product code
- QAN
- Decision date
- 2026-04-14
- Generic name
- Stent, iliac vein
- Approval order statement
- add Cook Polymer Technology as an additional supplier of the polytetrafluoroethylene tubing used in the delivery system component
Current openFDA PMA Record#
- Device
- Zilver® Vena® Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S009
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2026-04-14
- Decision code
- OK30
- Date received
- 2026-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- add Cook Polymer Technology as an additional supplier of the polytetrafluoroethylene tubing used in the delivery system component