PMA P240028S001

Device: WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
Applicant: EBR Systems, Inc.
PMA number: P240028
Supplement: S001
Product code: SEG
Decision date: 2025-06-18
Classification: Cardiovascular
Generic name: Leadless Cardiac Resynchronization Therapy (CRT)
Approval order statement: approval of the The WiSE-UP Registry (The WiSE System Utilization & Performance Registry) post-approval study protocol

Current openFDA PMA Record#

Device: WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System
Applicant: EBR Systems, Inc.
PMA number: P240028
Supplement: S001
Product code: SEG
Generic name: Leadless Cardiac Resynchronization Therapy (CRT)
Decision date: 2025-06-18
Decision code: APPR
Date received: 2025-05-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the The WiSE-UP Registry (The WiSE System Utilization & Performance Registry) post-approval study protocol