BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P930022 · Decision Feb 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    MEDTRONIC(R) LEGEND PLUS(TM) PULSE GENERATOR
    PMA Number
    P930022
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 7, 1997
    Date Received
    July 21, 1993
    Expedited Review
    N
    Docket Number
    97M-0121

    Advisory Committee Statement

    APPROVAL FOR THE LEGEND PLUS(R) PACING SYSTEM INCLUDING THE LEGEND PLUS(R) PULSE GENERATOR MODELS 8446 AND 8448; THE MODEL 9790 AND 9790C PROGRAMMERS WITH THE MODEL 9891 BASELINE SOFTWARE AND WITH THE MODE 9807 SOFTWARE. THIS SYSTEM IS INDICATED FOR PERMANENT VENTRICULAR OR ATRIAL PACING APPLICATIONS. ITS USE IS INDICATED IN THE TREATMENT OF PATIENTS WHO MAY BENEFIT FROM A PCING RATE THAT CHAGNES IN RESPONSE TO ACTIVITY. VENTRICULAR INDICATIONS INCLUDE: 1)CHRONIC ATRIAL FLUTTER OR FIBRILLATION WITH SLOW VENTRICULAR RESPONSE; 2)SINUS NODE DYSFUNCTIONS OR SICK SINUS SYNDROME (E.G., SINUS BRADYCARDIA, SINUS ARREST AND/OR EXIT BLOCK, BRADYCARDIATACHYCARDIA SYNDROME, CHRONOTROPIC INSUFFICIENCY, ETC.,); AND 3)AV BLOCK. ATRIAL INDICATIONS INCLUDE:1)SINUS NODE DYSFUNCTION OR SICK SINUS SYNDROME (E.G., SINUS BRADYCARDIA, SINUS ARREST AND/OR EXIT BLOCK, BRADYCARDIATACHYCARDIA SYNDROME, ETC.,) WITH INTACT AV CONDUCTION

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable