Venovo Venous Stent System

FDA Premarket Approval P180037 S009

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

DeviceVenovo Venous Stent System
Generic NameStent, Iliac Vein
ApplicantBard Peripheral Vascular, Inc.1625 West Third Streettempe, AZ 85281 PMA NumberP180037 Supplement NumberS009 Date Received03/25/2022 Decision Date04/22/2022 Product Code QAN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-03-25
Decision Date2022-04-22
PMAP180037
SupplementS009
Product CodeQAN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBard Peripheral Vascular, Inc.
1625 West Third Street
tempe, AZ 85281 PMA NumberP180037 Supplement NumberS009 Date Received03/25/2022 Decision Date04/22/2022 Product Code QAN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
delivery System Manufacturing Process And Inspection Changes For The 10 French Device Size

Supplemental Filings

Supplement NumberDateSupplement Type
P180037Original Filing
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

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