BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    PMA: P030017 · Supplement: S201 · Decision Aug 28, 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 SPECTRA SYSTEM
    PMA Number
    P030017
    Supplement Number
    S201
    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
    August 28, 2014
    Date Received
    June 2, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO THE PRECISION SPECTRA OBSERVATIONALMECHANICAL GATEWAY (OMG) DIRECTIONS FOR USE. THE PROPOSED CHANGE IS TO ADD THE ST JUDE PENTA LEAD (MODEL # 3228) TO THE TABLE OF COMPATIBLE ST. JUDE LEADS IN THE DIRECTIONS FOR USE. IN ADDITION, A STATEMENT WAS ADDED TO THE INTENDED USE SECTION TO REFER TO THE PRECISION SPECTRA SYSTEM MANUALS FOR THE INDICATIONS AND CONTRAINDICATIONS.

    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