BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pacemaker Pulse-Generator

    PMA: P890003 · Supplement: S055 · Decision Aug 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28

    Basic Information

    Device Name
    Implantable Pacemaker Pulse-Generator
    Trade Name
    MODEL 9790C PROGRAMMER AND MODEL 9891 PE SOFTWARE
    PMA Number
    P890003
    Supplement Number
    S055
    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
    August 12, 1998
    Date Received
    April 20, 1998
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site lcoated at Medtronic Puerto Rico, Inc.,(MPRI), Road 149, Rm. 56.3, Vilalba, Puerto Rico 00755.

    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