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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 NumberS002
Date Received06/12/2025
Decision Date07/10/2025
Product Code SEQ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
implementation of changes to the Austenite finish (Af) temperature specification for the Nitinol Connector Frame of the EndoForce Connector for Endovascular Venous Anastomosis
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