BioMimics 3D Vascular Stent System

FDA Premarket Approval P180003 S004

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

A change to a packaging film material

DeviceBioMimics 3D Vascular Stent System
Generic NameStent, Superficial Femoral Artery
ApplicantVeryan Medical Ltd.
Date Received2021-03-17
Decision Date2021-04-15
PMAP180003
SupplementS004
Product CodeNIP 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
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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