BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

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

    PMA: P920032 · Supplement: S003 · Decision Jul 19, 1996
    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
    Supplement Number
    S003
    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
    July 19, 1996
    Date Received
    January 19, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    ALTERNATE VENDOR FOR THE CALIBRATED MODULE ASSEMBLY FOR THE MICRO-PACE MODEL 4553, PART NUMBER 02-025-000

    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)