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Product name:Algovita™ Spinal Cord Stimulation System (some technology formerly Cirtec Medical) Some Available leads:Surpass™ Surgical Lead (8 Contacts) Product name: "Senza® Omnia™ SCS System, The Senza® System, Senza II™ System"ĭevice Name in Originial FDA Approval:Nevro Senza Spinal Cord Stimulation (SCS) SystemĪpproval Number (Link to FDA site with Supplements): P130022 Some Available leads:CoverEdge™ & CoverEdge X 32 Surgical Leads (32 contacts), Linear ST xxcm (8 contacts), Avista™ MRI Lead (8 contacts) SCS Lead Portfolio Lead Adapters Product name: Precision Spectra™, Spectra™ Plus, Spectra WaveWriter™, Precision Novi™, Precision Montage™ MRIĭevice Name in Originial FDA Approval: Precision Spinal Cord Stimulation (SCS) SystemsĪpproval Number (Link to FDA site with Supplements): P030017
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Tripole (16 contacts), Lamitrode™ Exclaim™ leads (8 contacts), 3186 Octrode™ lead (8 contacts), 3228 Penta™ lead (20 contacts) Paddle Leads & Percutaneous Leads Genesis and Eon Family Neurostimulation (IPG) SystemsĪpproval Number (Link to FDA site with Supplements):Īdditional Company / Product links > Device Name in Originial FDA Approval: Product name: Proclaim™ XR, Proclaim™ Elite, Proclaim™ DRG Neurostimulator System, Prodigy MRI™įDA approval product code: LGW (Genesis and Eon Family Neurostimulation (IPG) Systems), PMP(Axium Neurostimulator System) Device Name in Originial FDA Approval: (some technology formerly Advanded Neuromodulaiton Systems. Specify™ SureScan™ MRI surgical leads (16 contacts) Some Available leads: Vectris™ SureScan™ MRI percutaneous leads (8 contacts), (some technology formerly Stimgenics, LLC)ĭevice Name in Originial FDA Approval: Intellis Spinal Cord Stimulation (SCS) SystemsĪpproval Number (Link to FDA site with Supplements): P840001
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The information below summarizes FDA approvals for Spinal Cord Stimulation devices. Spinal cord stimulation is regulated in the USA by the FDA.