BioMimics 3D Vascular Stent System
FDA premarket approval P180003/S006 · decided 2022-04-05
Approval details
- PMA number
- P180003
- Supplement
- S006
- 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
- 2022-03-09
- Decision date
- 2022-04-05
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Horsham
- Statement
- Retain stents in production following an in-process quality control test.
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