BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P840001 · Supplement: S219 · Decision Mar 20, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55

    Basic Information

    Device Name
    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
    Trade Name
    SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM
    PMA Number
    P840001
    Supplement Number
    S219
    Device Class
    FDA Class 3
    Product Code
    LGW
    Generic Name
    Stimulator, spinal-cord, totally implanted for pain relief
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 20, 2013
    Date Received
    July 3, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR OF THE MEDTRONIC SURESCANTM MRI IMPLANTABLE NEUROSTIMULATION SYSTEM, WHICH CONSISTS OF THE PRIMEADVANCED SURESCAN¿ MRI IPG MODEL 97702; RESTOREULTRA SURESCAN¿ MRI IPG MODEL 97712; RESTOREADVANCED SURESCAN¿ MRI IPG MODEL 97713;RESTORESENSOR SURESCAN¿ MRI IPG MODEL 97714; VECTRIS SURESCANTM MRI 1X8 SUBCOMPACT LEADS MODELS 977A160, 977A175, AND 977A190; VECTRIS SURESCANTM MRI 1X8 COMPACT LEADS MODELS 977A260, 977A275, AND 977A290; VECTRIS 1X8 SUBCOMPACT TRIALING LEAD MODEL977D160; VECTRIS 1X8 COMPACT TRIALING LEAD MODEL 977D260; PATIENT PROGRAMMER MODEL 97740; PATIENT RECHARGER KIT MODEL 97754; N¿VISION APPLICATION CARD, VERSION AAP01 MODEL 8870; CLINICIAN PROGRAMMER MODEL 8840; EXTERNAL ANTENNA MODEL 37092; EXTERNALNEUROSTIMULATOR MODEL 37022; AND EXTERNAL NEUROSTIMULATOR MODEL 37021. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC SURESCAN¿ MRI IMPLANTABLE NEUROSTIMULATION SYSTEM AND IS INDICATED AS FOLLOWS.THE MEDTRONIC SURESCAN MRI IMPLANTABLE NEUROSTIMULATION SYSTEM IS INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE, UNILATERAL OR BILATERAL PAIN ASSOCIATED WITHTHE FOLLOWING:1) FAILED BACK SYNDROME OR LOW BACK SYNDROME OR FAILED BACK;2) RADICULAR PAIN SYNDROME OR RADICULOPATHIES RESULTING IN PAIN SECONDARY TO FAILEDBACK SYNDROME;3) POST LAMMECTOMY PAIN;4) UNSUCCESSFUL DISK SURGERY;5) DEGENERATIVE DISK DISEASE (DDD)/ HERNIATED DISK PAIN REFRACTORY TO CONSERVATIVE AND SURGICAL INTERVENTIONS;6)PERIPHERAL CAUSALGIA; 7) EPIDURAL FIBROSIS;8) ARACHNOIDITIS OR LUMBAR ADHESIVE ARACHNOIDITIS;9) COMPLEX REGIONAL PAIN SYNDROME (CRPS) OR REFLEX SYMPATHETIC DYSTROPHY (RSD) OR CAUSALGIA; AND 10) MULTIPLE BACK OPERATIONS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief