BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P000020 · Decision Nov 29, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    STINGER ABLATION CATHETER; TEMPLINK EXTENSION CABLE
    PMA Number
    P000020
    Device Class
    FDA Class 3
    Product Code
    LPB
    Generic Name
    Cardiac ablation percutaneous catheter
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    November 29, 2000
    Date Received
    May 4, 2000
    Expedited Review
    N
    Docket Number
    01M-0460

    Advisory Committee Statement

    APPROVAL FOR THE STINGER(TM) ABLATION CATHETER AND TEMPLINK(TM) EXTENSION CABLE. THE DEVICE IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS, AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI.

    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