BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Programmer, Pacemaker

    PMA: P910077 · Supplement: S014 · Decision Nov 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Programmer, Pacemaker
    Trade Name
    MODEL 2901 PROGRAMMER
    PMA Number
    P910077
    Supplement Number
    S014
    Device Class
    FDA Class 3
    Product Code
    KRG
    Generic Name
    Programmer, pacemaker
    Regulation Number
    870.3700
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 7, 1996
    Date Received
    March 25, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A 1)NEW PROGRAMMING SYSTEM, THE MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VENTAK PRXII/PRXIII, MINI PULSE GENERTORS AND ACCESSORIES, AND 2) A NEW MANUFACTURING CONTRACT FACILITY, EMD ASSOCIATES, INC. (EMD), 4065 THEURER BLVD., WINONA, MN 55987

    Classifications

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

    Product Code Device Name
    KRG Programmer, Pacemaker