BioMimics 3D Vascular Stent System

FDA Premarket Approval P180003 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Updates to the labeling with final clinical data from the mimics-2 study

DeviceBioMimics 3D Vascular Stent System
Generic NameStent, Superficial Femoral Artery
ApplicantVeryan Medical Ltd.
Date Received2020-06-25
Decision Date2020-08-13
PMAP180003
SupplementS003
Product CodeNIP 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Veryan Medical Ltd. unit 15, City Business Centre, Brighton Rd horsham RH13

Supplemental Filings

Supplement NumberDateSupplement Type
P180003Original Filing
S006 2022-03-09 30-day Notice
S005 2021-10-14 Normal 180 Day Track
S004 2021-03-17 30-day Notice
S003 2020-06-25 Normal 180 Day Track No User Fee
S002 2020-03-16 30-day Notice
S001 2020-03-02 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05391526850527 P180003 000
05391526850398 P180003 000
05391526850404 P180003 000
05391526850411 P180003 000
05391526850428 P180003 000
05391526850435 P180003 000
05391526850442 P180003 000
05391526850459 P180003 000
05391526850466 P180003 000
05391526850473 P180003 000
05391526850480 P180003 000
05391526850497 P180003 000
05391526850503 P180003 000
05391526850510 P180003 000
05391526850381 P180003 000

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