BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P950022 · Supplement: S001 · Decision Apr 23, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    TVL(TM) LEAD SYSTEM
    PMA Number
    P950022
    Supplement Number
    S001
    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
    April 23, 1997
    Date Received
    October 15, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    N

    Advisory Committee Statement

    APPROVAL FOR RV LEAD MODEL RV03, SVC LEAD MODELS SV04 AND SV05 WITH A SOLID SUTURE SLEEVE, STYLET MODELS S-70-4, S-70-F, S-45-X, S-55-X AND S-70-X AND FOR USE OF A LSER PROCESS TO REMOVE EXCESS SILICONE RUBBER FROM THE DEFIBRILLATION COILS.

    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)