BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P830026 · Supplement: S066 · Decision Mar 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    RX5000(TM) PROGRAMMER
    PMA Number
    P830026
    Supplement Number
    S066
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 22, 1996
    Date Received
    February 1, 1996
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INTRODUCTION OF LABELING ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY, THE FOLLOWING MODELS ARE AFFECTED:COSMOS II 284-05/283-03 -- NOVA II 282-04/281-05/281-05S/282-04R/282-04Y -- QUANTUM II 254-30/253-25 -- NOVA III 282-09/282-09R/282-07/281/07 -- QUANTUM III 254-27 -- SUPRIMA III 254-31

    Classifications

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

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)