Zilver Flex(R) 35 Vascular Stent
FDA premarket approval P050017/S024 · decided 2025-07-01
Approval details
- PMA number
- P050017
- Supplement
- S024
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Zilver Flex(R) 35 Vascular Stent
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Cook Ireland, Ltd.
- Date received
- 2024-09-27
- Decision date
- 2025-07-01
- Days to decision
- 277 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Limerick
- Statement
- The Zilver Flex® 35 Vascular Stent is intended to improve the luminal diameter in the treatment of de novo or restenotic symptomatic lesions in the native above-the-knee femoropopliteal arteries with reference vessel diameters from 4 to 7 mm and lesion lengths up to 190 mm
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