BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P960040 · Supplement: S306 · Decision Apr 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    DYNAGEN EL & MINI ICD'S; INOGEN EL & MINI ICD'S; ORIGEN EL & MINI ICD'S; TELIGEN ICD
    PMA Number
    P960040
    Supplement Number
    S306
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 11, 2014
    Date Received
    September 30, 2013
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES:1) NEW PULSE GENERATOR MODELS LISTED ABOVE AND MODIFICATIONS TO THE MODEL 2868 PROGRAMMER APPLICATION SOFTWARE USED TO COMMUNICATE WITH THE NEW DEVICES AND EXISTING DEVICES; AND 2) MODEL 3140 ZOOM WIRELESS TRANSMITTER AND ASSOCIATED MODIFICATIONS TO THE MODEL 3120 PRM SOFTWARE.

    Classifications

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

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)