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

    Catheter, Coronary, Atherectomy

    PMA: P130005 · Supplement: S051 · Decision Mar 10, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Catheter, Coronary, Atherectomy
    Trade Name
    Diamondback 360™ Coronary Orbital Atherectomy System; Diamondback 360 Precision™ Coronary Orbital Atherectomy System
    PMA Number
    P130005
    Supplement Number
    S051
    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
    March 10, 2026
    Date Received
    February 13, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the adoption of Abbott Vascular (AV) environmental monitoring testing procedures for Abbott Vascular Houston (AVH) and Abbott Vascular St. Paul (AVSP) facilities and to replace the current supplier for environmental monitoring testing with Abbott Vascular Temecula (AVT) and Abbott Vascular Westford (AVW) as the laboratory testing sites

    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