Atlas FDA

Veryan BioMimics 3D Vascular Stent System

FDA premarket approval P180003/S001 · decided 2020-03-27

Approval details

PMA number
P180003
Supplement
S001
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Veryan BioMimics 3D Vascular Stent System
Generic name
STENT, SUPERFICIAL FEMORAL ARTERY
Applicant
Veryan Medical, Ltd.
Date received
2020-03-02
Decision date
2020-03-27
Days to decision
25 days
Decision code
OK30
Product code
NIP
Advisory committee
Cardiovascular
Expedited review
No
Location
Horsham
Statement
Automate a portion of the label printing process.

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