BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P010012 · Supplement: S570 · Decision Oct 19, 2023
    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
    Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT)
    PMA Number
    P010012
    Supplement Number
    S570
    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 19, 2023
    Date Received
    May 8, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    updated labeling to include information regarding the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) Post Approval Studies [ (PAS 1) PAS for the MADIT-CRT Indicated Patient Population, Utilizing Data from the NCDR ICD Registry; (PAS 2) Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy Post Approval Registry]

    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)