Identity
- Trade Name
- BioMimics 3D Vascular Stent System FDA PMA
- Generic Name
- STENT, SUPERFICIAL FEMORAL ARTERY FDA PMA
Identifiers
- PMA Number
- P180003 FDA PMA
- FDA Product Code
- NIP FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The BioMimics 3D Vascular Stent System is an implantable stent 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. It is designed for use in vessels with reference diameters ranging from 4.0 to 6.0 mm and lesion lengths up to 140 mm.
The device is supplied by Veryan Medical, Ltd. and has received FDA PMA approval (P180003). It is intended for endovascular implantation in peripheral arteries and is not described as sterile, single-use, reusable, or MRI safe in the provided data. No information on sizes beyond diameter and length ranges, storage conditions, or additional authorisations is included in the specifications.
Frequently asked questions
What is the BioMimics 3D Vascular Stent System indicated to treat?
The BioMimics 3D Vascular Stent System 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, based on the approval statement in the device data.
What are the vessel size limits for the BioMimics 3D Vascular Stent System?
The device is indicated for use in native superficial femoral and/or proximal popliteal arteries with reference vessel diameters ranging from 4.0 to 6.0 mm and lesion lengths up to 140 mm, as stated in the approval documentation.
Who manufactures the BioMimics 3D Vascular Stent System and what is its FDA submission number?
The BioMimics 3D Vascular Stent System is manufactured by Veryan Medical, Ltd., and its FDA Premarket Approval number is P180003, as shown in the applicant and PMA number fields.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P180003 | Class III | Active |
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Manufacturer
- Manufacturer
- Veryan Medical, Ltd.
Sources (1)
- FDA PMA P180003 24 fields · synced Sep 18, 2026