BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P930039 · Supplement: S107 · Decision Oct 13, 2014
    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
    MEDTRONIC CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 LEAD
    PMA Number
    P930039
    Supplement Number
    S107
    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
    October 13, 2014
    Date Received
    April 17, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING THE 5076 CAPSUREFIX NOVUS LEAD TO THE MR CONDITIONALPACING FAMILY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CAPSUREFIX NOVUS MRI SURESCAN MODEL 5076 AND IS INDICATED FOR USE AS A SYSTEM CONSISTING OF A MEDTRONIC MRI SURESCAN IPG IMPLANTED WITH SURESCAN LEADS. A COMPLETE SYSTEM IS REQUIRED FOR USE IN THEMRI ENVIRONMENT.

    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