BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P890043 · Supplement: S038 · Decision Jan 14, 2005
    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
    S038
    Device Class
    FDA Class 3
    Product Code
    MCX
    Generic Name
    CATHETER, CORONARY, ATHERECTOMY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 14, 2005
    Date Received
    December 21, 2004
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO ALLOW STERILE PRODUCT RELEASE BASED ON DEMONSTRATION OF CONFORMITY TO PRE-DEFINED STERILIZATION PARAMETERS (PARAMETRIC RELEASE) RATHER THAN RELEASE BASED ON DEMONSTRATING NO GROWTH OF BIOLOGICAL INDICATORS (CONVENTIONAL RELEASE).

    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