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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 NumberS001
Date Received07/10/2023
Decision Date08/09/2023
Product Code QWM 
Advisory Committee Cardiovascular
Clinical TrialsNCT03119233
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) protocol.
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