BioMimics 3D Vascular Stent System
FDA premarket approval P180003/S012 · decided 2025-06-26
Approval details
- PMA number
- P180003
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BioMimics 3D Vascular Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Veryan Medical, Ltd.
- Date received
- 2024-12-05
- Decision date
- 2025-06-26
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Horsham
- Statement
- Approval for modifications to the delivery system and packaging; addition of an alternative contract manufacturer for the assembly for the subject device, modifications to the sterilization cycle and new sterilization site, and implementation of electronic IFU and labeling modifications
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