BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P960030 · Decision Jan 29, 1998
    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
    PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
    PMA Number
    P960030
    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
    January 29, 1998
    Date Received
    September 9, 1996
    Expedited Review
    N
    Docket Number
    98M-0605

    Advisory Committee Statement

    Approval for the Passive Plus(R) DX Endocardial, Steroid Eluting, Passive-Fixation Pacing Leads, Models 1342T, 1343K, 1346T, and 1345K. This device is indicated for use in combination with a compatible pulse generator to provide permanent pacing and sensing in either the atrium (Models 1342T or 1343K) or ventricle (Models 1345K or 1346T).

    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