BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P960013 · Decision Jun 20, 1997
    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
    TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
    PMA Number
    P960013
    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 20, 1997
    Date Received
    May 10, 1996
    Expedited Review
    N
    Docket Number
    98M-0450

    Advisory Committee Statement

    APPROVAL FOR THE TENDRIL(R) DX MODELS 388T/K ENDOCARDIAL, STEROID ELUTING, SCREW-IN PACING LEADS AND VENTRITEX ASSURE(TM) AFS MODELS 7010T/K ENDOCARDIAL, STERIOID ELUTING SCREW-IN PACING LEADS. THESE DEVICES ARE INDICATED FOR USE IN COMBINATION IWTH A COMPATIBLE PULSE GENERATOR TO PROVIDE PERMANENT PACING AND SENSING IN EITHER THE ATRIUM OR VENTRICLE.

    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