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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 NumberS002
Date Received07/31/2025
Decision Date11/18/2025
Product Code QAN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a design ownership and legal manufacturer located at Philips Image Guided Therapy Corporation (Philips), 5905 Nathan Lane North, Plymouth, MN 55442 and 9965 Federal Drive, Colorado Springs, CO 80921 USA
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