BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S202 · Decision Dec 19, 2014
    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
    PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
    PMA Number
    P030017
    Supplement Number
    S202
    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
    December 19, 2014
    Date Received
    June 30, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE PRECISION M8 ADAPTER THAT WILL BE USED TO CONNECT THE PRECISION IMPLANTABLE PULSE GENERATOR (IPG) OR THE PRECISION SPECTRA IPG TO THE FOLLOWING MEDTRONIC (MDT) SCS LEADS: SPECIFY 2X8 MODEL 39286, SPECIFY 5-6-5 MODEL 39565, LX8 COMPACT MODEL 3778, LX8 STANDARD MODEL 3777, LX8 SUB-COMPACT MODEL 3776, TEST: LX8, COMPACT MODEL 3874, TEST: LX8 STANDARD MODEL 3873, TEST: LX8 SUB-COMPACT MODEL 3875, MODEL 37081 EXTENSION, MODEL 37083 EXTENSION, MODEL 37082 EXTENSION, VECTRIS SURESCAN® MRI LX8 SUBCOMPACT, MODEL 977A160, 977A175, 977A190, AND VECTRIS SURESCAN® MRI LX8 COMPACT, MODEL 977A260, 977A275, 977A290.

    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