FDA.reportPublic FDA data

WiSE CRT System

Primary DI
00859244007043
Brand
WiSE CRT System
Company
EBR Systems, Inc.
Model
1000
Device description
Receiver Electrode Delivery Catheter
Published
2025-05-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
SEGLeadless Cardiac Resynchronization Therapy (Crt)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SEGLeadless Cardiac Resynchronization Therapy (Crt)Unknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240028000WiSE® (Wireless Stimulation of the Endocardium Technology) CRT SystemEBR Systems, Inc.2025-04-11SEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859244007043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859244007043008592440070438592440070430859244007043

GMDN Terms#

Term, Definition table
TermDefinition
Left-ventricular wireless pacing system transducer/electrodeA device consisting of an endocardial electrode with an ultrasound transducer intended to be implanted within the left ventricle of the heart to receive ultrasound (US) pulses from a parent transmitter and convert these into electrical pacing impulses to pace the left ventricle for cardiac resynchronization therapy (CRT) with a separate co-implanted pacemaker. It consists of a small electrode with a transducer intended to be attached to the endocardium. It is intended as an alternative to left-ventricular pacing using a coronary venous pacing lead. Disposable devices dedicated to implantation (e.g., delivery catheter) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Devices should be stored in their original packages in a dry, room temperature environment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
4087201906ebr.ra@ebrwise.com

Regulatory Flags#

DUNS number
151420580
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859244007005WiSE CRT System41002025-05-07
00859244007029WiSE CRT System31002025-05-07
00859244007067WiSE CRT System20002025-05-07
00859244007296WiSE CRT System51002025-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859244007005WiSE CRT SystemEBR Systems, Inc.SEG2025-05-07
00859244007029WiSE CRT SystemEBR Systems, Inc.SEG2025-05-07
00859244007067WiSE CRT SystemEBR Systems, Inc.SEG2025-05-07
00859244007296WiSE CRT SystemEBR Systems, Inc.SEG2025-05-07