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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceBioMimics 3D Vascular Stent System
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantVeryan Medical Ltd.
Unit 15, City Business Centre, Brighton Rd
Horsham RH13
PMA NumberP180003
Date Received01/09/2018
Decision Date10/04/2018
Product Code NIP 
Docket Number 18M-3841
Notice Date 10/19/2018
Advisory Committee Cardiovascular
Clinical TrialsNCT02400905
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
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