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Abbott Spinal Cord Stimulation (SCS) Systems – P010032/S191

Abbott’s Spinal Cord Stimulation (SCS) System is an implantable device, called a neurostimulator, to treat long-term (chronic) pain of the torso, arms, and legs

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: Abbott SCS System, including Prodigy, Proclaim Plus, Proclaim XR, and Eterna Systems
PMA Applicant: Abbott Medical
Address: 6901 Preston Road, Plano, TX 75024 USA
Approval Date: May 30, 2024
Approval Letter: Approval Order Statement

What is it?

Abbott’s Spinal Cord Stimulation (SCS) System is an implantable device, called a neurostimulator, to treat long-term (chronic) pain of the torso, arms, and legs that is difficult to manage (intractable). The Abbott SCS system includes an implantable pulse generator (IPG) and lead wires, as well as the external clinician programmer and patient controller. 

The Abbott SCS System can produce several types of stimulation that vary in strength, speed, and frequency. “Tonic” stimulations use a consistent stream of strong pulses, and “burst” stimulations use groups of milder and faster pulses.

This supplement specifies that both kinds of stimulation can be used to treat non-surgical back pain, but that diabetic peripheral neuropathy should only be treated with tonic stimulation.

 
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