BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    PMA: P970013 · Supplement: S019 · Decision May 9, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Pulse-Generator, Single Chamber, Sensor Driven, Implantable
    Trade Name
    MICRONY FAMILY PACEMAKERS
    PMA Number
    P970013
    Supplement Number
    S019
    Device Class
    FDA Class 3
    Product Code
    LWO
    Generic Name
    Pulse-generator, single chamber, sensor driven, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 9, 2007
    Date Received
    April 23, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 3330 VERSION6.1.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND MODEL 3307 VERSION 6.4.1 SOFTWARE FOR THE MODEL 3510 PROGRAMMER WHICH ENABLES V-V TIMING, AF SUPPRESSION AND QUICKOPT TIMING CYCLE OPTIMIZATION IN THE FRONTIER II MODEL 5586 CRT-P DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES AS SPECIFIED IN THE DEVICE FAMILIES AND IS INDICATED FOR RATE ADAPTIVE PACING, CARDIOVERSION AND DEFIBRILLATION AND/OR TREATMENT OF HEART FAILURE WITH CARDIAC RESYNCHRONIZATION THERAPY.

    Classifications

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

    Product Code Device Name
    LWO Pulse-Generator, Single Chamber, Sensor Driven, Implantable