PMA P200023S005
- Device
- Zilver Vena Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S005
- Product code
- QAN
- Decision date
- 2023-04-10
- Classification
- Cardiovascular
- Generic name
- Stent, iliac vein
- Approval order statement
- Update the stent cleaning and electropolishing workstation and cleaning agent.
Current openFDA PMA Record#
- Device
- Zilver Vena Venous Self-Expanding Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P200023
- Supplement
- S005
- Product code
- QAN
- Generic name
- Stent, iliac vein
- Decision date
- 2023-04-10
- Decision code
- OK30
- Date received
- 2023-03-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the stent cleaning and electropolishing workstation and cleaning agent.