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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.
 
DeviceDETOUR System
Generic NameStent graft, bypass, superficial femoral artery
ApplicantEndologix, LLC
3910 Brickway Blvd.
Santa Rosa, CA 95403
PMA NumberP220021
Supplement NumberS006
Date Received08/28/2025
Decision Date10/09/2025
Product Code QWM 
Advisory Committee Cardiovascular
Clinical TrialsNCT03119233
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  
a manufacturing site located at Endologix, LLC at 3910 Brickway Blvd., Santa Rosa, CA 95403 for manufacturing the TORUS Stent Graft System and associated manufacturing changes and for an alternate contract sterilizer for the TORUS Stent Graft System located at Steris Isomedix Services at 43425 Business Park Drive, Temecula, CA 92590
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