BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P920015 · Supplement: S106 · Decision Apr 12, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MODEL 5019 HV SPLITTER/ADAPTOR
    PMA Number
    P920015
    Supplement Number
    S106
    Device Class
    FDA Class 3
    Product Code
    LWS
    Generic Name
    Implantable cardioverter defibrillator (non-CRT)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 12, 2013
    Date Received
    March 21, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNALSUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS;2) AN ADDITIONAL SUPPLIER FOR EXTRUDED TUBING;TRANSFER OF INCOMING INSPECTION LOCATION FOR VARIOUS COMPONENTS;3) MODIFICATIONS TO A CONTROLLED ENVIRONMENT; AND4)AN ALTERNATE SUPPLIER OF A SILICONE COMPONENT.

    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)