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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceBioMimics 3D Vascular Stent System
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Veryan Medical Ltd.
unit 15, city business centre, brighton rd
horsham RH13
PMA NumberP180003
Date Received01/09/2018
Decision Date10/04/2018
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 18M-3841
Notice Date 10/19/2018
Advisory Committee Cardiovascular
Clinical Trials NCT02400905
Expedited Review Granted? No
Combination Product No
Approval Order 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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress