BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P910023 · Supplement: S309 · Decision Jun 6, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    ELLIPSE/FORTIFY ASSURA FAMILY OF ICDS
    PMA Number
    P910023
    Supplement Number
    S309
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 6, 2013
    Date Received
    November 14, 2012
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING NEW ELLIPSE/QUADRA ASSURA/FORTIFY ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS:1) ELLIPSE VR ICD (CD1411-36, CD1411-36Q, CD1411-36C, CD1411-36QC); 2) FORTIFY ASSURA VR ICD (CD1357-40, CD1357-40Q, CD1357-40C, CD1357-40QC);3) ELLIPSE DR ICD (CD2411-36, CD2411-36Q, CD2411-36C, CD2411-36QC);4) FORTIFY ASSURA DR ICD (CD2357-40, CD2357-40Q, CD2357-40C, CD2357-40QC);5) UNIFY ASSURA CRT-D (CD3357-40, CD3357-40Q, CD3357-40C, CD3357-40QC); AND 6) QUADRA ASSURA CRT-D (CD3365-40, CD3365-40Q, CD3365-40C, CD3365-40QC)AS WELL AS MODEL 3330 VERSION 17.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM PROGRAMMER, MODEL EX2000 VERSION 6.5 SOFTWARE FOR THE MODELS EX1150 AND EX1100 MERLIN@HOME TRANSMITTERS, AND MODEL MN5000 VERSION 6.5 SOFTWARE FOR THE MERLIN.NET SYSTEM.

    Classifications

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

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable