BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    PMA: P080006 · Supplement: S085 · Decision Feb 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22

    Basic Information

    Device Name
    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode
    Trade Name
    ATTAIN ABILITY MRI , PLUS MRI,STRAIGHT MRI SURESCAN; ATTAIN PERFORMA MRI, STRAIGHT ANS S MRI SURESCAN
    PMA Number
    P080006
    Supplement Number
    S085
    Device Class
    FDA Class 3
    Product Code
    OJX
    Generic Name
    Drug eluting permanent left ventricular (lv) pacemaker electrode
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 1, 2016
    Date Received
    September 24, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Amplia MRI/Amplia MRI Quad CRT-D SureScan and Compia MRI/Compia MRI Quad CRT-D SureScan devices, programmer application software Model SW034 and extension of MR Conditional labeling for the Attain Ability and Attain Performa lead models as MRI SureScan labeled leads.

    Classifications

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

    Product Code Device Name
    OJX Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode