BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P950022 · Supplement: S069 · Decision Jan 24, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    DURATA FAMILY OF LEADS
    PMA Number
    P950022
    Supplement Number
    S069
    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
    January 24, 2011
    Date Received
    April 22, 2010
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR 1) DESIGN MODIFICATIONS TO THE SUTURE SLEEVE OF ALL COMMERCIALLY AVAILABLE DURATA LEADS; 2) 7F SUTURE SLEEVE ACCESSORY KIT COMPATIBLE WITH ALL SJM 7F LEADS; 3) REDUCTION IN PVP (FASTPASS) COATING LENGTH FOR ALL DUAL-SHOCK VERSIONS OF COMMERCIALLY AVAILABLE DURATA LEADS; AND 4) DESIGN MODIFICATIONS TO THE IS-1 CONNECTOR CRIMP CONNECTION FOR ALL TRIFURCATED VERSIONS OF THE COMMERCIALLY- AVAILABLE DURATA LEADS.

    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)