Venovo Venous Stent System

FDA Premarket Approval P180037 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

New equipment for the stent sheath stretching process

DeviceVenovo Venous Stent System
Generic NameStent, Iliac Vein
ApplicantBard Peripheral Vascular, Inc.
Date Received2020-09-02
Decision Date2020-10-01
PMAP180037
SupplementS004
Product CodeQAN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Bard Peripheral Vascular, Inc. 1625 West Third Street tempe, AZ 85281

Supplemental Filings

Supplement NumberDateSupplement Type
P180037Original Filing
S004 2020-09-02 30-day Notice
S003 2020-08-31 30-day Notice
S002 2020-08-03 30-day Notice
S001 2020-08-03 30-day Notice

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