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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 NumberS005
Date Received03/10/2025
Decision Date09/18/2025
Product Code QWM 
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 manufacturing site located at Endologix, LLC at 3910 Brickway Blvd., Santa Rosa, CA 95403 for manufacturing the ENDOCROSS Device and associated manufacturing changes and for an alternate contract sterilizer for the ENDOCROSS Device located at Steris Isomedix Services at 43425 Business Park Drive, Temecula, CA 92590
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