BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P930029 · Supplement: S018 · Decision Dec 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE
    PMA Number
    P930029
    Supplement Number
    S018
    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
    December 17, 2002
    Date Received
    November 4, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CABLE THAT WILL ALLOW A MEDTRONIC RADIO-FREQUENCY ABLATION CATHETER TO FUNCTION AS A DIAGNOSTIC CATHETER BY PROVIDING CONNECTIVITY TO AN EP RECORDING SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MEDTRONIC MODEL 4819 ABLATION CATHETER TO EP RECORDING SYSTEM CABLE AND IS INDICATED FOR USE DURING DIAGNOSTIC ELECTROPHYSIOLOGIC STUDIES IN CONJUNCTION WITH MEDTRONIC ELECTRODE CATHETERS. THE CABLE IS USED DURING ELECTROPHYSIOLOGY STUDIES TO CONNECT THE ELECTRODE CATHETER TO THE ECG RECORDING/ STIMULATION EQUIPMENT.

    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