BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    PMA: P010012 · Supplement: S380 · Decision Jan 21, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Implantable Pulse Generator, Pacemaker (Non-Crt)
    Trade Name
    EASYTRAK 2+ IS-1 CORONARY VENOUS STEROID ELUTING DUAL ELECTRODE PACE/SENSE LEADS
    PMA Number
    P010012
    Supplement Number
    S380
    Device Class
    FDA Class 3
    Product Code
    LWP
    Generic Name
    Implantable pulse generator, pacemaker (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    January 21, 2015
    Date Received
    November 28, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN ADDITION OF SILGLIDE COATING TO THE OUTER DISTAL SILICONE BODY TUBING TO EASE DELIVERY THROUGH AN INNER CATHETER 7 FRENCH AND ASSOCIATED LABEL CHANGES TO REBRAND THE LEAD AS EASYTRAK 2+.

    Classifications

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

    Product Code Device Name
    LWP Implantable Pulse Generator, Pacemaker (Non-Crt)