BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Device, Angioplasty, Laser, Coronary

    PMA: P910001 · Decision Feb 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3

    Basic Information

    Device Name
    Device, Angioplasty, Laser, Coronary
    Trade Name
    SPECTRANECTICS CVX-300 EXCIMER LASER SYSTEM
    PMA Number
    P910001
    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 19, 1993
    Date Received
    February 8, 1991
    Expedited Review
    N
    Docket Number
    93M-0086

    Advisory Committee Statement

    APPROVAL FOR THE SPECTRANETICS CVX-300(TM) EXCIMER LASER SYSTEM, INCLUDING THE MODELS PC1014 AND PC1017 LASER CATHETERS. THIS SYSTEM IS INDICATED FOR USE IN PATIENTS WITH SINGLE OR MULTIVESSEL CORONARY ARTERY DISEASE EITHER AS A STAND ALONE MODALITY OR IN CONJUNCTION WITH PERCUTANEOUS TRANSLUMINAL CORONARY BALLOON ANGIOPLASTY (PTCA) AND WHO ARE ACCEPTABLE CANDIDATES FOR CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. ADJUNCTIVE BALLOON ANGIOPLASTY WAS PERFORMED, AT THE CLINICAL INVESTIGATOR'S DISCRETION, IN 84 PERCENT OF THE LESIONS TREATED. CLINICAL EXPERIENCE HAS PROVIDED REASONABLE ASSURANCE THAT THE SPECTRANETICICS CVX-300(TM) EXCIMER LASER SYSTEM AND MULTIFIBER LASER CATHETERS ARE SAFE AND EFFECTIVE FOR THE FOLLOWING INDICATIONS:OCCLUDED SAPHENOUS VEIN BYPASS GRAFTS; OSTIAL LESIONS; LONG LESIONS (GREATER THAN 20 MM IN LENGTH); MODERATELY CALCIFIED STENOSES (HEAVILY CALCIFIED STENOSES ARE THOSE LESIONS THAT DEMONSTRATE COMPLETE CALCIFICATION WHEN IDENTIFIED UNDER FLUOROSCOPY PRIOR TO THE PROCEDURE. MODERATELY AND SLIGHTLY CALCIFIED STENOSES ARE ALL OTHERS.); TOTAL OCCLUSIONS TRAVERSABLE BY A GUIDEWIRE; AND LESIONS WHICH HAVE PREVIOUSLY FAILED BALLOON ANGIOPLASTY (THIS INCLUDES THOSE LESIONS THAT WERE TREATED UNSUCCESSFULLY BY PTCA. LESIONS THAT HAVE UNDERGONE A COMPLICATED PTCA PROCEDURE ARE NOT INCLUDED IN THIS CATEGORY.) THESE LESIONS MUST BE TRAVERSABLE BY A GUIDEWIRE AND COMPOSED OF ATHERSCLEROTIC PLAQUE AND/OR CALCIFIED MATERIAL. THE LESIONS SHOULD BE WELL DEFINED BY ANGIOGRAPHY.

    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