PMA P050017S025
- Device
- Zilver Flex® 35 Vascular Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S025
- Product code
- NIO
- Decision date
- 2025-10-22
- Classification
- Cardiovascular
- Generic name
- STENT, ILIAC
- Approval order statement
- requested updates to your device labeling, including the graphics, operating principles, precautions and procedural instructions
Current openFDA PMA Record#
- Device
- Zilver Flex® 35 Vascular Stent
- Applicant
- Cook Ireland, Ltd.
- PMA number
- P050017
- Supplement
- S025
- Product code
- NIO
- Generic name
- STENT, ILIAC
- Decision date
- 2025-10-22
- Decision code
- APPR
- Date received
- 2025-09-26
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- requested updates to your device labeling, including the graphics, operating principles, precautions and procedural instructions