BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P080015 · Supplement: S003 · Decision Feb 3, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    CERVISTA
    PMA Number
    P080015
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    MAQ
    Generic Name
    KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 3, 2011
    Date Received
    January 18, 2011
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SEVERAL CHANGES TO THE CERVISTA HPV 16/18 SOFTWARE AND LABELING. CHANGES INCLUDE THE COMPANY NAME CHANGE FROM THIRD WAVE TO HOLOGIC, NUMEROUS USER INTERFACE CHANGES, AND SEPARATING THE INVADER CALL REPORTER AND CERVISTA HPV 16/18 SOFTWARE ON TO SEPARATE CDS WITH NEW PART NUMBERS.

    Classifications

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

    Product Code Device Name
    MAQ Kit, Dna Detection, Human Papillomavirus