BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S067 · Decision Mar 2, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MEDTRONIC EN-TRUST 30J/35J ICD FAMILY
    PMA Number
    P980016
    Supplement Number
    S067
    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
    March 2, 2006
    Date Received
    January 23, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MINOR DESIGN CHANGE TO THE ICR (INTERCONNECT RIBBON) THAT CONNECTS THE FEEDTHROUGHS TO THE CONNECTOR MODULE BLOCKS AND MULTI BEAM CONTACTS FOR THE MEDTRONIC ENTRUST 30J/35J ICD FAMILY (D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC). SPECIFICALLY, THE INTERCONNECT RIBBON (ICR) THAT CONNECTS THE FEEDTHROUGHS TO THE CONNECTOR MODULE BLOCKS AND MULTI BEAM CONTACTS IS BEING MODIFIED TO PROVIDE A LAP-WELD JOINT AND THE BONDING OF THE SAME MATERIALS.

    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)