BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

    PMA: P920032 · Decision Mar 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
    Trade Name
    MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER
    PMA Number
    P920032
    Device Class
    FDA Class 2
    Product Code
    JOQ
    Generic Name
    Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)
    Regulation Number
    870.1750
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 10, 1994
    Date Received
    June 30, 1992
    Expedited Review
    N
    Docket Number
    94M-0129

    Classifications

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

    Product Code Device Name
    JOQ Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)