BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P910023 · Supplement: S071 · Decision Nov 6, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM WITH MODEL 3180-T TRANSMITTER (SOFTWARE VERSION 1.1) AND MODEL 3180-R
    PMA Number
    P910023
    Supplement Number
    S071
    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
    November 6, 2003
    Date Received
    October 7, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE HOUSECALL 2.0 SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HOUSECALL PLUS TRANSTELEPHONIC MONITORING SYSTEM AND IS INDICATED AS FOLLOWS: THE HOUSECALL PLUS SYSTEM IS INDICATED FOR USE IN PERFORMING REMOTE FOLLOW-UP MONITORING ON PATIENTS HAVING THE FOLLOWING ST. JUDE MEDICAL CARDIOVERTER/ DEFRIBRILLATORS: ATLAS DR MODEL V-240, ATLAS VR MODEL V-199, EPIC+ DR MODEL V-236, EPIC+ VR MODEL V-1961, EPIC DR MODEL V-235 AND EPIC VR MODEL V-197.

    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