BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Catheter, Coronary, Atherectomy

    PMA: P980037 · Supplement: S009 · Decision Jun 22, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    ANGIOJET RHEOLYTIC THROMBECTOMY CATHETER SYSTEM
    PMA Number
    P980037
    Supplement Number
    S009
    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
    June 22, 2004
    Date Received
    May 19, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE PUMP SET (ALSO CALLED THE PUMP SET PLUS) WHICH INCLUDED: 1) MODIFICATION TO THE PUMP OUTLET AND INLET FITTINGS; 2) CHANGES TO THE DEPTH OF THE CHECK BALL SEAT AND ELIMINATION OF THE CHECK BALL SPRING; 3) CHANGES TO THE PRIME SENSOR CUP; 4) CHANGES TO THE PISTON HEAD; 5) COLOR CHANGES TO THE LUER; AND 6) CHANGES TO THE PARATUBING ASSEMBLY.

    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