BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Defibrillator Electrodes

    PMA: P050046 · Supplement: S012 · Decision Mar 5, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36

    Basic Information

    Device Name
    Permanent Defibrillator Electrodes
    Trade Name
    ACUITY STEERABLE IS-1 LEADS
    PMA Number
    P050046
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    NVY
    Generic Name
    Permanent defibrillator electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 5, 2012
    Date Received
    December 2, 2011
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES: 1) ADDITION OF OPTINOVA AS SUPPLIER OF EXTRUDED POLYURETHANE TUBING; 2) MODIFICATION TO DIMENSIONAL TOLERANCES FOR EXTRUDED POLYURETHANE TUBING; 3) MODIFICATION TO POLYURETHANE TUBING SPECIFICATION FOR FOREIGN MATERIAL, BUBBLES, AND GEL INCLUSIONS; AND 4) REMOVAL OF REDUNDANT METHYLENE DIANILINE (MDA) RESIDUAL LEVEL REQUIREMENTS FOR EXTRUDED TUBING.

    Classifications

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

    Product Code Device Name
    NVY Permanent Defibrillator Electrodes