BioMimics 3D Vascular Stent System
FDA premarket approval P180003 · decided 2018-10-04
Approval details
- PMA number
- P180003
- Trade name
- BioMimics 3D Vascular Stent System
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Applicant
- Veryan Medical, Ltd.
- Date received
- 2018-01-09
- Decision date
- 2018-10-04
- Days to decision
- 268 days
- Decision code
- APPR
- Product code
- NIP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Horsham
- Statement
- Approval for the BioMimics 3D Vascular Stent System. The device is indicated to improve luminal diameter in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal arteries, with reference vessel diameters ranging from 4.0 - 6.0 mm and lesion lengths up to 140 mm.
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