SetPoint Programmer

Primary DI
00860013950248
Brand
SetPoint Programmer
Company
SetPoint Medical Corporation
Model
v2
Published
2025-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
SFJVagus Nerve Stimulator For Rheumatoid Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SFJVagus Nerve Stimulator For Rheumatoid ArthritisUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240039000SetPoint SystemSetPoint Medical2025-07-30SFJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013950248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013950248008600139502488600139502480860013950248

GMDN Terms#

Term, Definition table
TermDefinition
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation systemAn assembly of battery-powered devices intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). The vagus nerve stimulation (VNS) is provided through an implantable pulse generator, typically placed in the anterior chest wall, and leads that run subcutaneously to where their electrodes are implanted around the left vagus nerve. The system may be programmed externally following implantation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
957136315
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013950217SetPoint Charger and Docking StationK012025-08-12
00860013950224SetPoint ChargerE042025-08-12
00860013950231SetPoint Docking StationC012025-08-12
00860013950200SetPoint ImplantM012025-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013950217SetPoint Charger and Docking StationSetPoint Medical CorporationSFJ2025-08-12
00860013950224SetPoint ChargerSetPoint Medical CorporationSFJ2025-08-12
00860013950231SetPoint Docking StationSetPoint Medical CorporationSFJ2025-08-12
00860013950200SetPoint ImplantSetPoint Medical CorporationSFJ2025-08-06