BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P110016 · Supplement: S002 · Decision Jul 10, 2012
    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
    SAFIRE BLU DUO SP ABLATION CATHETERS
    PMA Number
    P110016
    Supplement Number
    S002
    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 10, 2012
    Date Received
    May 11, 2012
    Supplement Type
    Real-Time Process
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ALTERNATIVE PACKAGE CONFIGURATION FOR THE SUBJECT ABLATION CATHETERS. THE NEW PACKAGE CONFIGURATION WOULD CHANGE THE PREVIOUS COILED TRAY CONFIGURATION TO A TRAY WITH A STRAIGHT CONFIGURATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES SAFIRE BLU SP IRRIGATED ABLATION CATHETER, THERAPY COOL PATH SP (BI-DIRECTIONAL) ABLATION CATHETER, AND SAFIRE BLU DUO SP ABLATION CATHETER.

    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