BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P020025 · Supplement: S028 · Decision Jul 19, 2011
    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/PRIME XP CATHETER
    PMA Number
    P020025
    Supplement Number
    S028
    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
    Approved
    Decision Code
    APPR
    Decision Date
    July 19, 2011
    Date Received
    June 9, 2011
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR PACKAGING DESIGN CHANGE FOR THE BLAZER II/PRIME HTD CATHETERS ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510; CHILLI COOLED ABLATION SYSTEM ELECTROPHYSIOLOGY CABLES, MODELS M0046810 AND M004620620; AND BLAZER II XP AND BLAZER PRIME CARDIAC ABLATION CATHETERS ELECTROPHYSIOLOGY CABLES, MODELS M0046130 AND M0046510.

    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