BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P920047 · Supplement: S018 · Decision Feb 12, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    BLAZER RPM CARDIAC ABLATION CATHETERS
    PMA Number
    P920047
    Supplement Number
    S018
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 12, 2003
    Date Received
    August 28, 2002
    Supplement Type
    Normal 180 Day Track
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE BLAZER RPM CATHETER WHICH FEATURED MINOR DESIGN CHANGES (E.G., ADDITION OF THREE TRANSDUCER RINGS, LASER WELDED CENTER SUPPORT AND MULTIPLE COAXIAL DESIGN) TO THE BLAZER II CATHETER.

    Classifications

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

    Product Code Device Name
    LPB Cardiac Ablation Percutaneous Catheter