BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S210 · Decision Feb 13, 2015
    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 AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM
    PMA Number
    P030017
    Supplement Number
    S210
    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
    February 13, 2015
    Date Received
    November 24, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE PRECISIO S8 ADAPTER THAT WILL BE USED TO CONNECT THE PRECISION IMPLANTABLE PULSE GENERATOR (IPG) OR THE PRECISION SPECTRA IPG TO THE FOLLOWING ST. JUDE MEDICAL (SJM) SCS LEADS: 3283/3286/3268/3269 LAMITRODE S8, 3280 LAMITRODE 8, 3244/3262/3263 LAMITRODE 44, 3245/3264/3265 LAMITRODE 44C, 3208 LAMITRODE TRIPOLE 8, 3210LAMITRODE TRIPOLE 8C, 3288 LAMITRODE 88, 3289 LAMITRODE 88C, 3214 LAMITRODE TRIPOLE 16C, 3219 LAMITRODE TRIPOLE 16, 3228 PENTA, 3183/3186/3189/3191 OCTRODE, 3086 OCTRODE TRIAL LEAD KIT, 2283 8-CHANNEL ADAPTER, 3341/3342/ 3343/3346 DUAL 4 EXTENSION, 3382/3383/3386SINGLE 8 EXTENSION.

    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