PMA P200023S001
- Device
- Zilver Vena Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S001
- Product code
- QAN
- Decision date
- 2021-10-01
- Generic name
- Stent, iliac vein
- Approval order statement
- Approval for updates to the Instructions for Use.
Current openFDA PMA Record#
- Device
- Zilver Vena Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S001
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2021-10-01
- Decision code
- APPR
- Date received
- 2021-09-02
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the Instructions for Use.