- Physicians Office Resource

INS 977006 PAIN PC MRI US EMAN
Vanta™ AdaptiveStim™ - 977006

Device Description

An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: LGW

Device Name: Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: QRB

Device Name: Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy

Device Class: 3

Physical State: Pulse generator, leads, accessories, software

Definition: To relieve pain in patients with diabetic neuropathy

Submission Type ID: 2

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: An implantable pulse generator provides electrical stimulation to the spinal cord using implanted leads, resulting in pain relief

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: Spinal cord

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Identifiers

Device Id: 00763000411923

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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