BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P050029 · Decision Oct 10, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    HELIOS II ABLATION CATHETER
    PMA Number
    P050029
    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
    October 10, 2008
    Date Received
    August 23, 2005
    Expedited Review
    N
    Docket Number
    08M-0601

    Advisory Committee Statement

    APPROVAL FOR THE HELIOS II ABLATION CATHETER. THE HELIOS II ABLATION CATHETER IS INTENDED FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING, DELIVERING DIAGNOSTIC PACING STIMULI, AND FOR THE CREATION OF ENDOCARDIAL LESIONS TO TREAT PATIENTS WITH SUPRAVENTRICULAR (SVT) TACHYCARDIAS.IT IS INTENDED TO ELIMINATE ATRIOVENTRICULAR REENTRANT TACHYCARDIA (AVRT) IN PATIENTS WITH OVERT OR CONCEALED ACCESSORY PATHWAYS, TO ELIMINATE AV NODAL RE-ENTRANT TACHYCARDIA (AVNRT), AND TO CREATE COMPLETE AV NODAL BLOCK IN PATIENTS WITH DIFFICULT TO CONTROL VENTRICULAR RESPONSE TO ATRIAL FIBRILLATION.THE HELIOS II ABLATION CATHETER IS INTENDED FOR USE WITH THE BIOSENSE WEBSTER STOCKERT 70 RF GENERATOR VIA A BIOSENSE WEBSTER CABLE MODEL C6-MR10/MSTK-S (6 FOOT) OR C10-MR10/MSTK-S (10 FOOT). THE HELIOS II ABLATION CATHETER IS FOR USE ONLY WITH THE STEREOTAXIS MAGNETIC NAVIGATION SYSTEM (MNS) AND IS COMPATIBLE WITH THE CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS).

    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