BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S157 · Decision May 30, 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
    PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
    PMA Number
    P030017
    Supplement Number
    S157
    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
    May 30, 2013
    Date Received
    March 4, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN UPDATING TO THE CLINICIAN PROGRAMMER COMPUTER USED WITH THE PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS. A TABLET COMPUTER FROM ASUS, MODEL EEE SLATE B121, WILL BE USED TO REPLACE THE CURRENT CLINICIAN PROGRAMMER, A TOSHIBA MODEL M400 LAPTOP COMPUTER. THE ASUS TABLET IS AN OFF-THE-SHELF COMPUTER, CUSTOMIZED TO BE A CLINICIANS PROGRAMMER BY INSTALLING THE EEE SLATE B121 BOOT AND IMAGE SOFTWARE AND CONFIGURING THE SYSTEM WITH THE BN1.2 AND BN3 BIONICNAVIGATOR SOFTWARE.

    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