PMA P200023S007
- Device
- Zilver Vena Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S007
- Product code
- QAN
- Decision date
- 2024-02-08
- Classification
- Cardiovascular
- Generic name
- Stent, iliac vein
- Approval order statement
- changes to the materials used in your delivery system sheath assembly
Current openFDA PMA Record#
- Device
- Zilver Vena Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S007
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2024-02-08
- Decision code
- APPR
- Date received
- 2023-10-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the materials used in your delivery system sheath assembly