BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P900070 · Supplement: S020 · Decision Oct 7, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MODEL 1256D META MV CARDIAC PULSE GENERATOR
    PMA Number
    P900070
    Supplement Number
    S020
    Device Class
    FDA Class 3
    Product Code
    DXY
    Generic Name
    implantable pacemaker Pulse-generator
    Regulation Number
    870.3610
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 7, 1997
    Date Received
    September 10, 1997
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the change in companies from Telectronics to Pacesetter. The device, as modified, will be marketed under the brand name Pacesetter for the dual chamber pacing models of the META(TM) DDDR Model 1250H Pulse Generator (hereinafter referred to as the META(TM) DDDR) which is indicated where maintenance of atrio-ventricular synchrony is required. This requirement is associated with the generally accepted indication for permanaent cardiac pacing which includes, but are not limited to: 1) sick sinus node syndorme; 2)symptomatic bradycardia; 3)symptomatic A-V block; 4)recurrent Stokes-Adams syndrome; 5)carotid sinus syncope; and 6)suppression of tachycardia.

    Classifications

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

    Product Code Device Name
    DXY Implantable Pacemaker Pulse-Generator