BioMimics 3D Vascular Stent System
FDA premarket approval P180003/S010 · decided 2024-09-20
Approval details
- PMA number
- P180003
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BioMimics 3D Vascular Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Veryan Medical, Ltd.
- Date received
- 2024-08-23
- Decision date
- 2024-09-20
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Horsham
- Statement
- approval for the addition of an expiration specification for incoming packaging materials
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