BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P060040 · Supplement: S002 · Decision Dec 3, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    THORATEC HEARTMATE II LVAS
    PMA Number
    P060040
    Supplement Number
    S002
    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
    December 3, 2008
    Date Received
    November 20, 2008
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A CAUTION STATEMENT ''WARNING: PRECLOT THEGRAFT!" TO THE PACKAGE LABELS FOR THE OUTFLOW GRAFT WITH BEND RELIEF (CATALOG# 102563) ANDINFLOW CONDUIT (CATALOG # 102564). THIS CAUTION STATEMENT IS TO HIGHLIGHT INFORMATION CURRENTLYFOUND IN THE HEARTMATE II INSTRUCTIONS FOR USE, SECTION 13.4, WHICH INSTRUCTS USERS TO PRE-CLOT THE TWO COMPONENTS PRIOR TO IMPLANTATION.

    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