BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S389 · Decision Feb 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    VITUOSO DR, VIRTUOSO VR, VIRTUOSO II DR, VIRTUOSO II VR, SECURA DR, SECURA VR, PROTECTA XT DR, PROTECTA XT VR
    PMA Number
    P980016
    Supplement Number
    S389
    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
    February 5, 2013
    Date Received
    November 7, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CLARIFICATIONS TO THE INDICATIONS FOR USE STATEMENTS RELATED TO THE OPTIVOL FEATURE AND OTHER MODIFICATIONS TO THE DEVICE LABELING. THE DEVICES ARE INDICATED AS FOLLOWS: DUAL CHAMBER ICDSTHE <DEVICE NAME> DR SYSTEM IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. IN ADDITION, THE DEVICE IS INDICATED FOR USE IN THE ABOVE PATIENTS WITH ATRIALTACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK OF DEVELOPING ATRIAL TACHYARRHYTHMIAS. NOTES:1) THE USE OF THE DEVICE HAS NOT BEEN DEMONSTRATED TO DECREASE THE MORBIDITY RELATED TO ATRIAL TACHYARRHYTHMIAS.2) THE EFFECTIVENESS OF HIGH-FREQUENCY BURST PACING (ATRIAL 50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 17%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO BE 16.8%, IN THE VT/AT PATIENT POPULATION STUDIED. 3) THE EFFECTIVENESS OF HIGH-FREQUENCY BURST PACING (ATRIAL 50 HZ BURST THERAPY) IN TERMINATING DEVICE CLASSIFIED ATRIAL TACHYCARDIA (AT) WAS FOUND TO BE 11.7%, AND IN TERMINATING DEVICE CLASSIFIED ATRIAL FIBRILLATION (AF) WAS FOUND TO 18.2% IN THE AF-ONLY PATIENT POPULATION STUDIED.SINGLE CHAMBER ICDS: THE <DEVICE NAME> VR SYSTEM IS INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS.

    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)