mySCS™ GO

GUDID 00191506020705

Therapy Controller App

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer Implantable spinal cord electrical stimulation system programmer

• Primary Device ID: 00191506020705
• NIH Device Record Key: 9b3b3590-5939-486b-94d5-bc8abe7b081b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mySCS™ GO
• Version Model Number: SC-5275
• Company DUNS: 824951958
• Company Name: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191506020705 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030017

FDA Product Code

• QRB: Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-30
• Device Publish Date: 2024-04-22

On-Brand Devices [mySCS™ GO]

• 00191506020705: Therapy Controller App
• 00191506020606: Therapy Controller
• 00191506020583: Therapy Controller