BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P950022 · Supplement: S034 · Decision Mar 8, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    RIATA FAMILY OF LEADS
    PMA Number
    P950022
    Supplement Number
    S034
    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 8, 2007
    Date Received
    December 19, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES:1)MODIFICATION TO THE CRIMP SLUG WELD TAB 2) MODIFICATION TO THE DISTAL HEADER ASSEMBLY 3) MODIFICATION TO THE PTFE LINER IN THE IS-1 CONNECTOR LEG 4) REMOVAL OF THE PTFE LINERS IN THE TWO DF-1 CONNECTOR LEGS 5) ADDITION OF A DF-1 PLUG ACCESSORY TO THE LEAD PACKAGE 6) ADDITION OF AN EXTRA-SOFT STYLET ACCESSORY TO THE LEAD PACKAGE 7) MINOR MODIFICATIONS TO THE USER MANUAL 8) MODIFIED RADIUS SPECIFICATION FOR THE SPRING STOPPER 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)