BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Cardiac Ablation Percutaneous Catheter

    PMA: P030031 · Supplement: S006 · Decision Nov 28, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52

    Basic Information

    Device Name
    Cardiac Ablation Percutaneous Catheter
    Trade Name
    NAVISTAR THERMOCOOL CATHETER FOR TREATMENT OF TYPE I ATRIAL FLUTTER
    PMA Number
    P030031
    Supplement Number
    S006
    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
    November 28, 2007
    Date Received
    September 17, 2007
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol - OSB
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE POST-APPROVAL STUDY PROTOCOL.

    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