Venovo Venous Stent System

FDA Premarket Approval P180037 S008

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 in configuration of the j1 joint of the delivery system

DeviceVenovo Venous Stent System
Generic NameStent, Iliac Vein
ApplicantBard Peripheral Vascular, Inc.
Date Received2021-10-15
Decision Date2021-12-16
PMAP180037
SupplementS008
Product CodeQAN 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
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
S008 2021-10-15 Real-time Process
S007 2021-08-09 Normal 180 Day Track No User Fee
S006 2021-07-09 30-day Notice
S005 2021-05-04 30-day Notice
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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