BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S280 · Decision May 2, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    PROTECTS XT VR, PROTECTA VR, SECURA VR MAXIMO II ICD
    PMA Number
    P980016
    Supplement Number
    S280
    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
    May 2, 2012
    Date Received
    February 9, 2011
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MEDTRONIC PROTECTA¿ XT VR D314VRM, PROTECTA¿ VR D334VRM, SECURA® VR D204VRM, MAXIMO II® VR D264VRM ICD SYSTEMS, MODEL 9995 APPLICATION SOFTWARE V7.3 AND MODEL SW009 APPLICATION SOFTWARE VL.0 SYSTEMS.

    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)