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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.
 
DeviceDuo Venous Stent System
Generic NameStent, iliac vein
ApplicantPhilips Image Guided Therapy Corporation
5905 Nathan Ln. N.
Plymouth, MN 55442
PMA NumberP230021
Supplement NumberS001
Date Received01/13/2025
Decision Date02/11/2025
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 Vesper Medical operating location
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