SetPoint Implant

Basic Information

• Brand Name: SetPoint Implant
• Primary DI: 00860013950200
• Version / Model: M01
• Company Name: SetPoint Medical Corporation
• Labeler DUNS: 957136315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-06
• Public Version: 2
• Public Version Date: 2025-11-21
• Public Version Status: Update
• Public Device Record Key: c5a23fd9-9d04-4e67-9df2-59886fc62bb8

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
SFJ	Vagus Nerve Stimulator For Rheumatoid Arthritis	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
67653	Arthritis-therapy vagus nerve implantable electrical stimulator	A battery-powered implantable device intended to apply periodic electrical stimuli to the vagus nerve (neuroimmune modulation) to reduce inflammation, pain, and bone erosion associated with arthritis [e.g., rheumatoid arthritis (RA)]. It consists of a small pulse generator with integrated stimulation electrodes, which is designed to be surgically placed adjacent to the vagus nerve, typically in the neck region. Devices intended to support implant function (wearable battery charger, charger docking station, professional programming software) are commonly supplied with the implant.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860013950200	GS1

Premarket Submissions

Submission Number	Supplement Number
P240039	000