BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Applicator, Hyperthermia, Interstitial

    PMA: P880078 · Supplement: S009 · Decision Aug 31, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Applicator, Hyperthermia, Interstitial
    Trade Name
    VH8500 HYPERTHERMIA TREATMENT SYSTEM
    PMA Number
    P880078
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    LMZ
    Generic Name
    Applicator, hyperthermia, interstitial
    Medical Specialty
    Unknown
    Advisory Committee
    Radiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 31, 1992
    Date Received
    July 13, 1992
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LMZ Applicator, Hyperthermia, Interstitial