BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Ventricular (Assist) Bypass

    PMA: P870072 · Supplement: S012 · Decision Jun 1, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21

    Basic Information

    Device Name
    Ventricular (Assist) Bypass
    Trade Name
    THORATEC VENTRICULAR ASIST DEVICE
    PMA Number
    P870072
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    DSQ
    Generic Name
    Ventricular (assist) bypass
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 1, 2001
    Date Received
    September 25, 2000
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE TLC-II PORTABLE PNEUMATIC DRIVER TO THE THORATEC PARACORPOREAL VENTRICULAR ASSIST DEVICE SYSTEM. THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED TO BE INTERCHANGEABLE WITH THE DUAL DRIVE CONSOLE IN THE (CURRENTLY APPROVED) THORATEC PARACORPOREAL VENTRICULAR DEVICE SYSTEM FOR EITHER BRIDGE TO TRANSPLANT PATIENTS OR FOR POSTCARDIOTOMY RECOVERY PATIENTS WHO ARE UNABLE TO BE WEANED FROM CARDIOPULMONARY BYPASS. THE TLC-II PORTABLE PNEUMATIC DRIVER IS INTENDED FOR USE EITHER IN THE HOSPITAL OR IN A MEDICALLY MONITORED RESIDENCE FACILITY. IN ADDITION, THE TLC-II PORTABLE PNEUMATIC DRIVER CAN BE USED TO ALLOW SUITABLY QUALIFIED PATIENTS TO TAKE OFF-SITE EXCURSIONS WITHIN A TWO-HOUR TRAVEL RADIUS OF THE HOSPITAL IN THE COMPANY OF A TRAINED CAREGIVER.

    Classifications

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

    Product Code Device Name
    DSQ Ventricular (Assist) Bypass