Abiomed, Inc.

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Description

4 dispositivos en la base de datos

  • Modelo / Serial
    Serial numbers: 45921,45922,45923,45924
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    International only: Canada and France
  • Descripción del producto
    Impella 5.0 Circulatory Support System || Catalog number: 004840 || The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours
  • Modelo / Serial
    Serial Numbers: AD5001 through AD5496, except AD5006 and AD5018.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- United States, Australia, Brazil, China, Hong Kong, Japan, Mexico and Germany.
  • Descripción del producto
    Abiomed AB5000 Circulatory Support System, Catalog Number: 0015-0000. Manufactured by Abiomed, Inc. Danvers, MA. || Intended to provide complete short-term support of the left and/or right sides of the heart to patients suffering from potentially reversible ventricular dysfunction.
  • Modelo / Serial
    Serial numbers: AF0013 - AF0015, AF0017, AF0018, AF0020, AF0022-AF0024, AF0028, AF0030, AF0037, AF0038, AF0043, AF0049, and AF0053 - AF0055.
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA, including states of AL, IN, FL, NJ, NY, and OH and countries of Germany, Greece, and Sweden.
  • Descripción del producto
    Abiomed AB5000 Portable Driver || Catalog number: 0025-0000 || The AB5000 System is a mechanical circulatory support system for use in patients suffering from potentially reversible ventricular dysfunction. It can also be used to facilitate patient transport . The Driver is external to the patient and is intended for short-term use.
  • Modelo / Serial
    Serial numbers: SC1000, SC1001, SC1003 - SC1010, SC1014 - SC1023, SC1025 - SC1070, SC1072 - SC1081, SC1083, SC1084, and SC1089
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Domestic: MA, MI, SC, NY, NJ, OH, CA, PA, AR, MI, MD, CT, IL, WI, TX, NJ, TN, IN, MI, DE, FL, IA, WA, KY, and WV Foreign: Germany, Greece, Italy, Latvia, Spain, and Turkey
  • Descripción del producto
    iPulse Circulatory Support System || Catalog number: 0036-0010 || The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPulse console can be used to drive exclusively one of two classes of therapeutic devices: either pneumatically actuated Ventricular Assist Devices (VADs) for total circulatory support, or (i.e., non-simultaneously) an intra-aortic balloon (IAB) catheter for counter-pulsation therapy.

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Más información acerca de la data acá

  • Dirección del fabricante
    Abiomed, Inc., 22 Cherry Hill Drive, Danvers MA 01923
  • Source
    USFDA
  • Dirección del fabricante
    Abiomed, Inc., 22 Cherry Hill Dr, Danvers MA 01923-2575
  • Source
    USFDA