BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Angioplasty, Laser, Coronary

    PMA: P910001 · Supplement: S059 · Decision Apr 4, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Device, Angioplasty, Laser, Coronary
    Trade Name
    EXCIMER LASER CORONARY ATHERECTOMY (ELCA) CATHETER
    PMA Number
    P910001
    Supplement Number
    S059
    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
    April 4, 2013
    Date Received
    July 2, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE TO AN ADHESIVE PRIMER USED IN THE MANUFACTURE OF THE ELCA ECCENTRIC (ELL) DEVICES. PREVIOUSLY, YOU HAVE USED LOCTITE 793 WHICH HAS BEEN DISCONTINUED BY THE VENDOR. THE PRIMER HAS BEEN CHANGED TO LOCTITE 7701, A MEDICAL GRADE ADHESIVE PRIMER USED FOR THE SAME PURPOSE.

    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