BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Invasive Bone Growth

    PMA: P850035 · Supplement: S053 · Decision May 7, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Stimulator, Invasive Bone Growth
    Trade Name
    SpF Implantable Spinal Fusion Stimulators
    PMA Number
    P850035
    Supplement Number
    S053
    Device Class
    FDA Class 3
    Product Code
    LOE
    Generic Name
    Stimulator, invasive bone growth
    Medical Specialty
    Unknown
    Advisory Committee
    Orthopedic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 7, 2018
    Date Received
    April 9, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Qualify and implement redesigned, manufacturing, work area layouts, installation of a new environmental monitoring (HEMS) system and complementary clean room equipment within the ISO Class 8 Environmentally Controlled Clean Room Area (CEA) and its corresponding ISO Class 8 Adjacent Gowning Room at Guaynabo, Puerto Rico Manufacturing and Distribution Facility.

    Classifications

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

    Product Code Device Name
    LOE Stimulator, Invasive Bone Growth