BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse-Generator, Single Chamber, Single

    PMA: P860007 · Supplement: S017 · Decision Mar 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Pulse-Generator, Single Chamber, Single
    Trade Name
    INTERTACH(R)II MODELS 262-16
    PMA Number
    P860007
    Supplement Number
    S017
    Device Class
    FDA Class 3
    Product Code
    LWW
    Generic Name
    PULSE-GENERATOR, SINGLE CHAMBER, SINGLE
    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 LABELNG ADDRESSING COMPATIBILITY OF PACEMAKERS WITH CELLULAR TELEPHONES. SPECIFICALLY THE FOLLOWING MODELS ARE AFFECTED:INTERTACH II 262-16/262-16R

    Classifications

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

    Product Code Device Name
    LWW Pulse-Generator, Single Chamber, Single