BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Electrode Recording, Or Probe, Electrode Recording

    PMA: P990071 · Supplement: S003 · Decision Oct 21, 2002
    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 RF GENERATOR WITH SOFTWARE VERSION 1.033
    PMA Number
    P990071
    Supplement Number
    S003
    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
    October 21, 2002
    Date Received
    October 1, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO MODIFY THE STOCKERT 70 GENERATOR SO AS TO DELIVER UP TO 70 WATTS OF POWER WHEN USED WITH THE NAVISTAR DS AND CELSIUS DS CATHETERS. THE STOCKERT 70 RF GENERATOR IS INDICATED FOR USE IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CATHETER ABLATION PROCEDURES.

    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