Venovo Venous Stent System

FDA Premarket Approval P180037 S006

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

To implement an alternative external process challenge device (epcd) used in the sterilization process

DeviceVenovo Venous Stent System
Generic NameStent, Iliac Vein
ApplicantBard Peripheral Vascular, Inc.
Date Received2021-07-09
Decision Date2021-08-05
PMAP180037
SupplementS006
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
S012 2023-01-06 30-day Notice
S011 2022-05-19 30-day Notice
S010 2022-04-26 30-day Notice
S009 2022-03-25 30-day Notice
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.