BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    PMA: P970013 · Supplement: S017 · Decision May 7, 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 OF PACEMAKERS
    PMA Number
    P970013
    Supplement Number
    S017
    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 7, 2007
    Date Received
    April 6, 2007
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE EPIC AND ATLAS FAMILIES OF ICDS AND CRT-DS, INCLUDING: ADDITION OF AN OVER-CURRENT PROTECTION CIRCUIT; ADDED CAPABILITY FOR RAM OPERATION WITH ROM BACKUP WITH DEFIBRILLATION ONLY (DFO) IN THE HARDWARE BACKUP MODE; ADDITION OF DAILY HIGH-VOLTAGE LEAD IMPEDANCE MEASUREMENTS; ADDITION OF LV RING TO RV COIL PACING PULSE CONFIGURATION; ADDITION OF VENTRICULAR INTRINSIC PREFERENCE FEATURE; AND MODIFICATIONS TO PROGRAMMER SOFTWARE AND DISPLAY ENHANCEMENTS. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES PROMOTE CRT-D DEVICE MODEL NUMBERS 3107-36 AND 3107-30, AND CURRENT DR AND VR ICD DEVICE MODEL NUMBERS 2107-36, 2107-30 AND 1107-36, 1107-30, AND WILL BE SUPPORTED BY THE MODEL 3650 MERLIN PCS WITH MODEL 3330 VERSION 6.0 SOFTWARE.

    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