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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.
 
DeviceEndoForce™ Connector for Endovascular Venous Anastomosis
Generic NameCovered stent vascular connector, hemodialysis access circuit
ApplicantPhraxis, Inc.
333 Hennepin Ave. E.
Minneapolis, MN 55114
PMA NumberP240004
Supplement NumberS001
Date Received06/06/2025
Decision Date07/18/2025
Product Code SEQ 
Advisory Committee Cardiovascular
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 EndoForce Post-Approval Study submitted to comply with the conditions of approval outlined in the approval order for P240004.
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