BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

    PMA: P020030 · Decision Jun 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26

    Basic Information

    Device Name
    Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
    Trade Name
    STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD
    PMA Number
    P020030
    Device Class
    FDA Class 3
    Product Code
    NVN
    Generic Name
    Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 17, 2004
    Date Received
    July 19, 2002
    Expedited Review
    N
    Docket Number
    04M-0310

    Advisory Committee Statement

    APPROVAL FOR THE STELID II, STELIX, AND STELIX II ENDOCARDIAL PACING LEADS. THE STELID II, STELIX, AND STELIX II ENDOCARDIAL STEROID ELUTING PACING LEADS ARE DESIGNED TO BE USED WITH AN IMPLANTABLE PACEMAKER FOR PACING AND SENSING OF THE HEART. THE STELID II MODELS BTF25D/26D AND UTF25D/26D ARE INTENDED FOR PERMANENT PACING AND SENSING OF THE VENTRICLE. THE STELID II MODELS BJF24D/25D, STELIX MODELS BR45D/46D, AND STELIX II MODELS BRF25D/26D ARE INTENDED FOR PERMANENT PACING AND SENSING OF THE ATRIUM.

    Classifications

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

    Product Code Device Name
    NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes