BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    PMA: P070008 · Supplement: S008 · Decision Mar 31, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25

    Basic Information

    Device Name
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
    Trade Name
    STRATOS LV AND LV-T PULSE GENERATORS
    PMA Number
    P070008
    Supplement Number
    S008
    Device Class
    FDA Class 3
    Product Code
    NKE
    Generic Name
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 31, 2009
    Date Received
    November 17, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) COMMERCIAL DISTRIBUTION OF THE LUMAX HF-T CRT-DS AND STRATOS LV (-T) CRT-PS WITH VENTRICLE TO VENTRICLE (V-V) DELAY FEATURES; AND 2) UPDATED MODEL ICS 3000 PROGRAMMER SOFTWARE (RELEASE OF 802.U/2) TO IMPLEMENT THE V-V DELAY FEATURES AND OTHER MINOR ENHANCEMENTS.

    Classifications

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

    Product Code Device Name
    NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)