Venovo Venous Stent System

FDA Premarket Approval P180037 S011

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 NumberS011 Date Received05/19/2022 Decision Date05/23/2022 Product Code QAN  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-19
Decision Date2022-05-23
PMAP180037
SupplementS011
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 NumberS011 Date Received05/19/2022 Decision Date05/23/2022 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 8 French Size

Supplemental Filings

Supplement NumberDateSupplement Type
P180037Original Filing
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

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