PMA P240004

Device: EndoForce Connector for Endovascular Venous Anastomosis
Applicant: Phraxis, Inc.
Product code: SEQ
Decision date: 2025-07-18
Generic name: Covered stent vascular connector, hemodialysis access circuit
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.

Current openFDA PMA Record

Device: EndoForce Connector for Endovascular Venous Anastomosis
Applicant: Phraxis, Inc.
PMA number: P240004
Supplement: S001
Product code: SEQ
Generic name: Covered stent vascular connector, hemodialysis access circuit
Decision date: 2025-07-18
Decision code: APPR
Date received: 2025-06-06
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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.