PMA P200023S004
- Device
- Zilver Vena® Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S004
- Product code
- QAN
- Decision date
- 2023-03-16
- Classification
- Cardiovascular
- Generic name
- Stent, iliac vein
- Approval order statement
- Alternative supplier of an adhesive used in the manufacture of the delivery system.
Current openFDA PMA Record#
- Device
- Zilver Vena® Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S004
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2023-03-16
- Decision code
- OK30
- Date received
- 2023-02-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative supplier of an adhesive used in the manufacture of the delivery system.