BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P990071 · Supplement: S016 · Decision Oct 31, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION
    PMA Number
    P990071
    Supplement Number
    S016
    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 31, 2012
    Date Received
    January 4, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR UPGRADING THE EXISTING ACCESSORY COOLFLOW IRRIGATION PUMP FOR THE STOCKERT 70 RADIOFREQUENCY (RF) GENERATOR FOR CARDIAC ABLATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTABLATE IRRIGATION PUMP AND SMARTABLATE TUBING SET. THE INDICATIONS ARE THAT THE SMARTABLATE IRRIGATION PUMP IS A PERISTALTIC PUMP DESIGNED TO WORK IN CONJUNCTION WITH THE STOCKERT 70 RADIOFREQUENCY GENERATOR TO DELIVER IRRIGATION SOLUTION AT SPECIFIED NOW RATES TO IRRIGATED CATHETERS (SUCH AS THE BIOSENSE WEBSTER CELSIUS THERMOCOOL CATHETERS AND NAVISTAR THERMOCOOL CATHETERS) FOR COOLING PURPOSES. THE PUMP IS USED WITH THE SMARTABLATE IRRIGATION TUBING SET THAT CONDUCTS THE IRRIGATION SOLUTION FROM AN EXTERNAL SOURCE TO THE COMPATIBLE IRRIGATED CATHETERS.

    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