Document issued on: April 6, 2012 The draft of this document was issued on April 29, 2010. OMB Control No. 0910-0705 Expiration Date: 3/31/2015 See additional PRA statement in Section VIII of this guidance For questions for the Center for Devices and Radiological Health regarding this document contact the Premarket Notification (510(k)) Section at 301-796-5640….
Comunicado de la FDA sobre la seguridad de los medicamentos: Recomendaciones modificadas para Celexa (citalopram bromhidrato) relacionadas con el riesgo potencial de ritmo cardiaco anormal con dosis altas
Recomendaciones modificadas para Celexa (citalopram bromhidrato) relacionadas con el riesgo potencial de ritmo cardiaco anormal con dosis altas. Esta actualización presenta información adicional relacionada con un previo Comunicado sobre la seguridad de los medicamentos de la FDA (publicado el 24/8/2011): Ritmo cardiaco anormal relacionado con dosis altas de Celexa (citalopram bromhidrato). Anuncio de seguridadInformación adicional…
Comunicado de la FDA sobre la seguridad de los medicamentos: La interacción entre ciertos medicamentos para el VIH o hepatitis C y los medicamentos con estatinas para reducir el colesterol, puede aumentar el riesgo de lesiones musculares
Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de datosLimitaciones en la dosis de estatinasReferencias Anuncio de seguridad El 1º de marzo del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) emitió recomendaciones actualizadas sobre la interacción entre medicamentos para el virus de…
Spectrum of Diseases/Conditions
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General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (June 21, 2012)
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The…
Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS): Class 1 Recall- Outflow Graft May Kink or Deform
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Class I Medical Device Recall: Thoratec Corporation, HeartMate II Left Ventricular Assist System (LVAS)
Recall Class: Class I Date Recall Initiated: February 23, 2012 Product: HeartMate II Left Ventricular Assist System (LVAS) Model/catalog/lot numbers: 103393, 103695, 104692, 104911, 104912 Range of manufacturing and distribution dates: February 2010 – February 2012 Use: The HeartMate II LVAS is indicated for use as a bridge to transplantation in heart transplant candidates at…
FDA Webinar on Safety of the Blood Supply
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Altuzan (bevacizumab): Counterfeit Product
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