Venovo Venous Stent System

FDA Premarket Approval P180037 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

An alternate supplier of delivery system handle lock marking and thermoplastic staking processes

DeviceVenovo Venous Stent System
Generic NameStent, Iliac Vein
ApplicantBard Peripheral Vascular, Inc.
Date Received2020-08-31
Decision Date2020-09-25
PMAP180037
SupplementS003
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.