Skip to content

WiSE CRT System 4100

by EBR Systems, Inc.

WiSE CRT System 4100 is a Class III device made by EBR Systems, Inc., approved under FDA PMA P240028 on 11 Apr 2025 and listed in FDA GUDID since 7 May 2025 (UDI-DI 00859244007005), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

PMA P240028

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00859244007005 UDI-DI Date7 May 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP240028 Date11 Apr 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P240028 decided 11 Apr 2025 Active
  • FDA GUDID UDI-DI 00859244007005 listed 7 May 2025 Listed

Timeline

2 dated events

  1. Approved FDA PMA P240028
  2. Listed FDA GUDID 00859244007005

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
WiSE CRT System
Generic name
Left-ventricular wireless pacing system sensor/transmitter
Model / reference
4100
Primary DI / UDI-DI
00859244007005
PMA number
FDA product code
SEG
GMDN term
Left-ventricular wireless pacing system sensor/transmitter
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Left-ventricular wireless pacing system sensor/transmitter

Cleared under the same submission (P240028)

Other devices from EBR Systems, Inc.

See all devices from EBR Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)