BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S363 · Decision Jan 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    ENTRUST ICD,INTRINSIC ICD,MARQUIS DR ICD,VR ICD,MAXIMO II ICD,VR ICD,PROTECTA ICD,XT ICD,SECURA ICD,VIRTUOSO ICD
    PMA Number
    P980016
    Supplement Number
    S363
    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
    January 3, 2013
    Date Received
    June 19, 2012
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - PAS
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO UPDATE THE DEVICE LABELING WITH THE RESULTS FROM THE RIGHT VENTRICULAR LEAD INTEGRITY ALERT (RV LIA) POST-APPROVAL STUDY (PAS).

    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)