PMA P240004S002

Device: EndoForce™ Connector for Endovascular Venous Anastomosis
Applicant: Phraxis, Inc.
PMA number: P240004
Supplement: S002
Product code: SEQ
Decision date: 2025-07-10
Classification: Cardiovascular
Generic name: Covered stent vascular connector, hemodialysis access circuit
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

Current openFDA PMA Record#

Device: EndoForce™ Connector for Endovascular Venous Anastomosis
Applicant: Phraxis, Inc.
PMA number: P240004
Supplement: S002
Product code: SEQ
Generic name: Covered stent vascular connector, hemodialysis access circuit
Decision date: 2025-07-10
Decision code: OK30
Date received: 2025-06-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
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