BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P890043 · Supplement: S037 · Decision Dec 5, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    FLEXI-CUT DIRECTIONAL DEBULKING SYSTEM
    PMA Number
    P890043
    Supplement Number
    S037
    Device Class
    FDA Class 3
    Product Code
    MCX
    Generic Name
    CATHETER, CORONARY, ATHERECTOMY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 5, 2001
    Date Received
    June 7, 2001
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR LABELING CHANGES FOR THE FLEXI-CUT(TM) DIRECTIONAL DEBULKING SYSTEM. THE LABELING CHANGES INCLUDE THE ADDITION OF A SUMMARY OF THE PHYSICIAN PREFERENCE TESTING INFORMATION, AND THE ADDITION OF A WARNING STATEMENT TO REMOVE ATHEROMATOUS TISSUE FROM THE NOSECONE FREQUENTLY TO AVOID GUIDEWIRE RESTRICTION.

    Classifications

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

    Product Code Device Name
    MCX Catheter, Coronary, Atherectomy