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

• Device: BioMimics 3D Vascular Stent System
• Generic Name: Stent, Superficial Femoral Artery
• Applicant: Veryan Medical Ltd.
• Date Received: 2020-06-25
• Decision Date: 2020-08-13
• PMA: P180003
• Supplement: S003
• Product Code: NIP
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: Veryan Medical Ltd. unit 15, City Business Centre, Brighton Rd horsham RH13

Supplemental Filings

Supplement Number	Date	Supplement Type
P180003		Original 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 ID	PMA	Supp
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