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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceVenovo Venous Stent System
Generic NameStent, iliac vein
ApplicantBard Peripheral Vascular, Inc.
1625 W Third St.
Tempe, AZ 85281
PMA NumberP180037
Supplement NumberS014
Date Received11/08/2024
Decision Date12/06/2024
Product Code QAN 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
a change to the porosity and inclusions in the stent raw material specifications
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