Zilver® Flex® 35 Vascular Stent; Zilver® 635® Vascular Stent; Zilver® 518® Vascular Stent
FDA premarket approval P050017/S026 · decided 2026-04-14
Approval details
- PMA number
- P050017
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Zilver® Flex® 35 Vascular Stent; Zilver® 635® Vascular Stent; Zilver® 518® Vascular Stent
- Generic name
- STENT, ILIAC
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2026-03-16
- Decision date
- 2026-04-14
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- add Cook Polymer Technology as an additional supplier of the polytetrafluoroethylene tubing used in the delivery system component
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