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510(k) Data Aggregation

    K Number
    K051773
    Device Name
    MODEL 3873 1* 8 AND MODEL 3874 1* 8 COMPACT TEST STIMULATION LEADS
    Date Cleared
    2005-07-28

    (27 days)

    Product Code
    Regulation Number
    882.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC INC.,NEUROLOGICAL DIVISION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Model 3873 1 x 8 and Model 3874 1 x 8 Compact Test Stimulation Leads are indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following: - Failed Back Syndrome or Low Back Syndrome or Failed Back; - Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed Back Syndrome; - Post Laminectomy Pain; - Unsuccessful Disk Surgery; - Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative and surgical interventions; - Peripheral Causalgia; - Epidural Fibrosis; - Arachnoiditis or Lumbar Adhesive Arachnoiditis; - Complex Regional Pain Syndtome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia; and, - Multiple Back Surgenes Additional Contraindication: The Medtronic Models 3873 1 x 8 and the 3874 1 x 8 Compact Test Stimulation Leads are contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.
    Device Description
    The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact are test stimulation lead kits. A test stimulation lead is a thin wire covered by an insulative coating, which is intended to be connected to a screening cable and an external neurostimulator (ENS). The lead has small metal electrodes near its tip through which the ENS delivers electrical stimulation to an area where pain signals will be blocked.
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