BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S536 · Decision Sep 11, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    EVERA MRI XT DR, XT VR, S DR, S VR SURESCAN ICD'S
    PMA Number
    P980016
    Supplement Number
    S536
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 11, 2015
    Date Received
    March 16, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF THE EVERA MRI XT/S DR AND VR IMPLANTABLE CARDIOVERTERDEFIBRILLATOR DEVICES AND PROGRAMMER APPLICATION SOFTWARE MODEL SW033 AS WELL AS EXTENSION OF MR CONDITIONAL LABELING AND USE FOR SPRINT QUATTRO SECURE LEAD MODELS 6935M AND 6947M AS MRI SURESCAN LABELED 55 AND 62CM LEADS. IN ADDITION TO THE SYSTEM COMPONENTS LISTED, THE USE OF THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI AND CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 WITH THE EVERA MRI DR (DUAL CHAMBER)SYSTEM WHEN AN ATRIAL PACE/SENSE LEAD IS INDICATED. FURTHERMORE, YOU REQUESTED APPROVAL TO USE CARELINK MONITOR MODEL 2490C, CARELINK EXPRESS MONITOR 2020B, CARDIOSIGHT READER MODEL2020A, MYCARELINK MONITOR MODEL 24950 AND DEVICE DATA MANAGEMENT APPLICATION (DDMA) MODEL 2491 TO PROVIDE PATIENT AND DEVICE DATA TRANSFER FROM THE EVERA MRI DEVICES.

    Classifications

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

    Product Code Device Name
    LWS Implantable Cardioverter Defibrillator (Non-Crt)