BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Permanent Pacemaker Electrode

    PMA: P960006 · Supplement: S001 · Decision Apr 9, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24

    Basic Information

    Device Name
    Permanent Pacemaker Electrode
    Trade Name
    SWEET PICOTIP(TM) RX STEROID ELUTING, POROUS TIP, POSITIVE FIXATION LEAD
    PMA Number
    P960006
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    DTB
    Generic Name
    permanent pacemaker Electrode
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 9, 1999
    Date Received
    October 2, 1998
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for several new lead models: the SWEET PICOTIP(TM) Rx Models 4050, 4051, 4052, 4053, 4054, and 4055 Steroid Eluting, Positive-Fixation, Porous Tip Pacing Leads. These devices are indicated for chornic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.

    Classifications

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

    Product Code Device Name
    DTB Permanent Pacemaker Electrode