BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010031 · Supplement: S125 · Decision Oct 23, 2008
    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
    CONCENTRO II CRT-D
    PMA Number
    P010031
    Supplement Number
    S125
    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
    October 23, 2008
    Date Received
    September 24, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO IMPLEMENT A DESIGN CHANGE TO ADD THREE NEW"INTERMEDIATE-FEATURE" MODELS (CONCERTO II MODEL CRT-D D274TRK. VIRTUOSO II ICD MODEL DRD274DRG AND MODEL VR D274VRC) TO THE APPROVED GEN 2 CONSULTA/SECURA/ MAXIMA II FAMILYOF DEVICES (CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK. SECURE VR D224VRC,MAXIMO II DR D284DRG, AND MAXIMO II D284 VRC SUBMITTED UNDER P01003I/S084 ANDP980016/S114, APPROVED MARCH 17, 2008).

    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)