BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Angioplasty, Laser, Coronary

    PMA: P910001 · Supplement: S124 · Decision Feb 6, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Device, Angioplasty, Laser, Coronary
    Trade Name
    ELCA Coronary Atherectomy Catheters
    PMA Number
    P910001
    Supplement Number
    S124
    Device Class
    FDA Class 3
    Product Code
    LPC
    Generic Name
    DEVICE, ANGIOPLASTY, LASER, CORONARY
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 6, 2026
    Date Received
    June 17, 2025
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    the use of alternate components in the adhesive supplied to Philips/Spectranetics for the sterile barrier of the packaging system

    Classifications

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

    Product Code Device Name
    LPC Device, Angioplasty, Laser, Coronary