BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Catheter, Electrode Recording, Or Probe, Electrode Recording

    PMA: P990071 · Supplement: S002 · Decision Feb 15, 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 RADIOFREQUENCY ABLATION GENERATOR
    PMA Number
    P990071
    Supplement Number
    S002
    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
    February 15, 2002
    Date Received
    November 29, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) ADAPTER CABLES (MODELS D-1170-27-001, D-1170-28-001, AND D-1170-29-001) THAT CONNECT THE STOCKERT 70 RF GENERATOR CABLE TO COMPATIBLE CATHETERS AND 2) A NEW INDICATIONS FOR USE FOR THE STOCKERT 70 RF GENERATOR. THE ADAPTER CABLES WILL BE MARKETED UNDER THE TRADE NAME STOCKERT 70 RF GENERATOR CABLE ADAPTERS FOR CARDIAC ABLATION. BOTH THE STOCKERT 70 RF GENERATOR CABLE ADAPTERS FOR CARDIAC ABLATION AND STOCKERT 70 RF GENERATOR ARE INDICATED FOR USE IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CARDIAC 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