EndoForce Connector for Endovascular Venous Anastomosis
FDA premarket approval P240004/S001 · decided 2025-07-18
Approval details
- PMA number
- P240004
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- EndoForce Connector for Endovascular Venous Anastomosis
- Generic name
- Covered stent vascular connector, hemodialysis access circuit
- Applicant
- Phraxis, Inc.
- Date received
- 2025-06-06
- Decision date
- 2025-07-18
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- SEQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- 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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