BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    PMA: P070008 · Decision May 12, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25

    Basic Information

    Device Name
    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
    Trade Name
    STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD
    PMA Number
    P070008
    Device Class
    FDA Class 3
    Product Code
    NKE
    Generic Name
    Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 12, 2008
    Date Received
    March 12, 2007
    Expedited Review
    N
    Docket Number
    08M-0335

    Advisory Committee Statement

    APPROVAL FOR THE STRATOS LV CRT-P AND STRATOS LV-T CRT-P WITH 702.U PROGRAMMER SOFTWARE FOR THE ICS 3000 AND COROX OTW BP LEAD AND COROX OTW-S BP LEAD. THE STRATOS LV CRT-P AND THE STRATOS LV-T CRT-P ARE INDICATED FOR PATIENTS WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS II1/IV), INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF< 35%) AND QRS > 120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY. THE COROX OTW BP AND COROX OTW-S BP LEFT VENTRICULAR PACING LEADS ARE BIPOLAR STEROID-ELUTING LEADS, INTENDED FOR PERMANENT IMPLANTATION IN THE LEFT VENTRICLE VIA THE CORONARY VEINS TO PROVIDE PACING AND/OR SENSING WHEN USED IN CONJUNCTION WITH A COMPATIBLE IS-1 PULSE GENERATOR.

    Classifications

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

    Product Code Device Name
    NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)