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

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    PMA: P020025 · Supplement: S051 · Decision Dec 18, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46

    Basic Information

    Device Name
    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
    Trade Name
    BLAZER II XP,BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS
    PMA Number
    P020025
    Supplement Number
    S051
    Device Class
    FDA Class 3
    Product Code
    OAD
    Generic Name
    catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 18, 2013
    Date Received
    November 21, 2013
    Supplement Type
    30-Day Notice
    Expedited Review
    N

    Advisory Committee Statement

    VENDOR MANUFACTURING CHANGES FOR THE BLAZER II, BLAZER II HTD, BLAZER PRIME HTD, BLAZER II XP, AND BLAZER PRIME XP ABLATION CATHETERS.

    Classifications

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

    Product Code Device Name
    OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter