Zilver Flex® 35 Vascular Stent
FDA premarket approval P050017/S025 · decided 2025-10-22
Approval details
- PMA number
- P050017
- Supplement
- S025
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Zilver Flex® 35 Vascular Stent
- Generic name
- STENT, ILIAC
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2025-09-26
- Decision date
- 2025-10-22
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- requested updates to your device labeling, including the graphics, operating principles, precautions and procedural instructions
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