BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Programmer, Pacemaker

    PMA: P830045 · Supplement: S072 · Decision Oct 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Programmer, Pacemaker
    Trade Name
    INTEGRITY/BRADYCARDIA REFERENCE/PATIENT MANUAL
    PMA Number
    P830045
    Supplement Number
    S072
    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
    October 2, 2000
    Date Received
    September 22, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE USERS MANUALS FOR THE INTEGRITY AFX DR MODEL 5342 AND SR MODEL 5142.

    Classifications

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

    Product Code Device Name
    KRG Programmer, Pacemaker