BioMimics 3D® Vascular Stent System
FDA premarket approval P180003/S011 · decided 2024-11-14
Approval details
- PMA number
- P180003
- Supplement
- S011
- Supplement type
- 30-Day Notice
- 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
- 2024-10-18
- Decision date
- 2024-11-14
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Horsham
- Statement
- approval for a material change to the ePCD pouches
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