BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Permanent, Implantable

    PMA: P960013 · Supplement: S025 · Decision May 7, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35

    Basic Information

    Device Name
    Pulse Generator, Permanent, Implantable
    Trade Name
    OPTISENSE MODEL 1699T/TC LEADS
    PMA Number
    P960013
    Supplement Number
    S025
    Device Class
    FDA Class 3
    Product Code
    NVZ
    Generic Name
    Pulse generator, permanent, implantable
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 7, 2007
    Date Received
    November 30, 2006
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE OPTISENSE MODEL 1699T AND 1699TC LEADS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OPTISENSE MODEL 1699T AND 1699TC LEADS AND ARE DESIGNED FOR PERMANENT SENSING AND PACING IN THE RIGHT ATRIUM, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. AN ACTIVE FIXATION LEAD SUCH AS THE MODEL 1699 MAY BE INDICATED FOR PATIENTS WHERE PERMANENT FIXATION OF PASSIVE LEADS IS SUSPECTED TO BE UNSTABLE. IN ATRIAL APPLICATIONS, THE USE OF A SCREW-IN LEAD MAY BE INDICATED IN THE PRESENCE OF AN ABNORMAL, SURGICALLY ALTERED OR EXCISED ATRIAL APPENDAGE.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NVZ Pulse Generator, Permanent, Implantable