BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Implantable Cardioverter Defibrillator (Non-Crt)

    PMA: P920015 · Supplement: S021 · Decision Jun 11, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49

    Basic Information

    Device Name
    Implantable Cardioverter Defibrillator (Non-Crt)
    Trade Name
    MODEL 6996 SQ LEAD SYSTEM AND 6996T TUNNELING TOOL
    PMA Number
    P920015
    Supplement Number
    S021
    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
    June 11, 2001
    Date Received
    February 5, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MODEL 6996 SQ LEAD SYSTEM AND THE 6996T TUNNELING TOOL. THE MODEL 6996 SQ LEAD SYSTEM IS FOR SINGLE, LONG-TERM SUBCUTANEOUS USE AND IS INTENDED FOR USE IN PATIENTS IN WHICH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD) ARE INDICATED. THE LEAD IS INTENDED FOR USE IF A STANDARD ICD SYSTEM WITH ONE OR TWO TRANSVENOUS LEADS HAS NOT BEEN EFFICACIOUS IN PROVIDING ACCEPTABLE DFT MEASUREMENTS. THE MODEL 6996 SQ LEAD IS INTENDED FOR USE ONLY WITH THE FOLLOWING SYSTEMS: A MEDTRONIC ICD FEATURING A CONNECTOR BLOCK WITH AT LEAST TWO DF-1 CONNECTOR PORTS; AND A MEDTRONIC RIGHT VENTRICULAR LEAD FOR DEFIBRILLATING/PACING/SENSING. IN ADDITION, A THIRD DEFIBRILLATION LEAD, SUCH AS ANY MEDTRONIC SVC LEAD, MAY BE USED WITH A LEAD ADAPTOR.

    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)