BioMimics 3D Vascular Stent System
FDA premarket approval P180003/S003 · decided 2020-08-13
Approval details
- PMA number
- P180003
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BioMimics 3D Vascular Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Veryan Medical, Ltd.
- Date received
- 2020-06-25
- Decision date
- 2020-08-13
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Horsham
- Statement
- Approval for updates to the labeling with final clinical data from the MIMICS-2 study.
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