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

    Pacemaker/Icd/Crt Non-Implanted Components

    PMA: P910077 · Supplement: S150 · Decision Jul 20, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34

    Basic Information

    Device Name
    Pacemaker/Icd/Crt Non-Implanted Components
    Trade Name
    LATITUDE INDUCTIVE COMMUNICATOR ; LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)
    PMA Number
    P910077
    Supplement Number
    S150
    Device Class
    FDA Class 3
    Product Code
    OSR
    Generic Name
    Pacemaker/icd/crt non-implanted components
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 20, 2015
    Date Received
    June 29, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REPLACE A WATER WASH SYSTEM FOR PRINTED CIRCUIT BOARD ASSEMBLIES.

    Classifications

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

    Product Code Device Name
    OSR Pacemaker/Icd/Crt Non-Implanted Components