BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Electrode Recording, Or Probe, Electrode Recording

    PMA: P990071 · Supplement: S005 · Decision Jun 6, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86

    Basic Information

    Device Name
    Catheter, Electrode Recording, Or Probe, Electrode Recording
    Trade Name
    STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
    PMA Number
    P990071
    Supplement Number
    S005
    Device Class
    FDA Class 2
    Product Code
    DRF
    Generic Name
    CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 6, 2005
    Date Received
    December 22, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MANUAL OPERATION OF THE COOLFLOW IRRIGATION PUMP WITH THE BIOSENSE WEBSTER THERMOCOOL CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COOLFLOW IRRIGATION PUMP. THE COOLFLOW IRRIGATION PUMP AND TUBING SET IS A PERISTALTIC IRRIGATION PUMP DESIGNED FOR THE DELIVERY OF SALINE SOLUTION WHEN USED IN CONJUNCTION WITH THE STOCKERT 70 RF GENERATOR AND THE THERMOCOOL IRRIGATION CATHETERS.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording