BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P980012 · Supplement: S006 · Decision Jul 21, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    WORLD HEART NOVACOR N100PC AND N100PCQ :VAS
    PMA Number
    P980012
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    DSQ
    Generic Name
    Ventricular (assist) bypass
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 21, 2004
    Date Received
    March 10, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE DEVICE SYSTEM LABELING; SPECIFICALLY, CHANGES TO (ONLY) THE DEVICE RELIABILITY PORTION OF SECTION 7 (CLINICAL STUDY) OF THE PHYSICIAN'S MANUAL.

    Classifications

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

    Product Code Device Name
    DSQ Ventricular (Assist) Bypass