BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    PMA: P060027 · Supplement: S038 · Decision May 9, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26

    Basic Information

    Device Name
    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
    Trade Name
    PARADYM RF CRT-D
    PMA Number
    P060027
    Supplement Number
    S038
    Device Class
    FDA Class 3
    Product Code
    NIK
    Generic Name
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 9, 2013
    Date Received
    March 13, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE SMARTVIEW HOME MONITOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTVIEW HOME MONITOR AND IS INDICATED FOR USE WITH SORIN RADIO FREQUENCY IMPLANTED CARDIAC DEVICE ONLY AND ANY HOUSEHOLD TRADITIONAL (ANALOG TYPE) TELEPHONE LAND LINE; IT WILL NOT OPERATE WITH OTHER LINES SUCH AS AND NOT LIMITED TO DIGITAL, DSL OR OPTICAL FOR THE PSTN DEVICE AND THE SMARTVIEW MONITOR IS DESIGNED FOR USE WITH THE SORIN RADIO FREQUENCY IMPLANTED CARDIAC DEVICE ONLY FOR GPRS DEVICES.

    Classifications

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

    Product Code Device Name
    NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)