BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

    PMA: P020052 · Supplement: S006 · Decision Jun 25, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
    Trade Name
    RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER
    PMA Number
    P020052
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    MTE
    Generic Name
    System, pacing, temporary, acute, internal atrial defibrillation
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 25, 2010
    Date Received
    May 27, 2010
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE.

    Classifications

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

    Product Code Device Name
    MTE System, Pacing, Temporary, Acute, Internal Atrial Defibrillation