BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P980016 · Supplement: S053 · Decision Aug 19, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS
    PMA Number
    P980016
    Supplement Number
    S053
    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
    August 19, 2005
    Date Received
    July 29, 2005
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS FOR THE FOLLOWING MODELS: MEDTRONIC ENTRUST MODEL D153ATG;MEDTRONIC ENTRUST MODEL D153DRG;MEDTRONIC ENTRUST MODEL D153VRC;MEDTRONIC ENTRUST MODEL D154ATG;MEDTRONIC ENTRUST MODEL D154DRG; ANDMEDTRONIC ENTRUST MODEL D154VRC.

    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)