BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P960013 · Supplement: S022 · Decision Oct 10, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS
    PMA Number
    P960013
    Supplement Number
    S022
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 10, 2006
    Date Received
    August 17, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS, MODELS 1281, 1282, 1283, 1291, 1292 AND 1293. THE LOCATOR PLUS STYLETS ARE SIMILAR TO THE APPROVED LOCATOR MODEL 4036 STEERABLE STYLET (PMA P960013/S010), BUT WITH SIX DIFFERENT COMBINATIONS OF TIP RADII AND STRAIGHT TIP LENGTHS. THE LOCATOR PLUS FAMILY OF DEFLECTABLE STYLETS ARE INTENDED FOR USE WHEN IMPLANTING COMPATIBLE ST. JUDE MEDICAL ACTIVE FIXATION STRAIGHT ENDOCARDIAL PACEMAKER LEADS, TENDRIL MODEL 1688 SDX AND HIGHER.

    Classifications

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

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable