BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P960004 · Decision Nov 12, 1996
    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
    THINLINE ENDOCARDIAL PACING LEADS
    PMA Number
    P960004
    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
    November 12, 1996
    Date Received
    January 29, 1996
    Expedited Review
    N
    Docket Number
    97M-0258

    Advisory Committee Statement

    APPROVAL FOR THE THINLINE(TM) MODELS 430-10 AND 432-04 ENDOCARDIAL PACING LEADS INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM 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
    NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes