BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S218 · Decision Nov 9, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MEDTRONIC PROTECTA XT DR D314DRM, PROTECTA DR D334DRM, CARDIOVERTER DEFIBRILLATORS
    PMA Number
    P980016
    Supplement Number
    S218
    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
    November 9, 2011
    Date Received
    December 23, 2009
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE PROTECTA XT CRT-D, D314TRM AND PROTECTA CRT-DD334TRM IMPLANTABLE CARDIOVERTCR DEFIBRILLATORS WITH CARDIAC RCSYNCHRONIZATION, PROTECTA XT DR D314DRM AND PROTECTA DR D334DRM IMPLANTABLE CARDIOVERTER DEFIBRILLAIORS, MODEL SW009 APPLICATION SOFTWARE VL.0, CARELINK MONITOR MODEL 2490C UPGRADE. CARDIOSIGHT READER MODEL 2020A UPGRADE AND MODEL 2491 DDMA UPGRADE.

    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)