Stakeholder Meeting on MDUFA III Reauthorization February 28, 2012, 1:30 – 3:15 PM HHS Humphrey Building, Washington, DC Room 305A Purpose To provide a status update of the ongoing MDUFA III negotiations. Participants FDA Malcolm Bertoni Office of the Commissioner (OC) Ashley Boam Center for Devices and Radiological Health (CDRH) Nathan Brown Office of Chief…
Flebogamma DIF 5%
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Consumer Information on: EverFlex Self-Expanding Peripheral Stent System
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Summary Information for: EverFlex Self-Expanding Peripheral Stent System
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Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall
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Postmarketing Requirements and Commitments: Reports
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PMA Final Decisions for January 2012
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Class I Medical Device Recall: Acclarent Inspira AIR Balloon Dilation System, size 18X40mm.
Recall Class: Class I Date Recall Initiated: January 30, 2012. Product: Acclarent Inspira AIR Balloon Dilation System, size 18x40mm, product code BC1840A, manufactured between March 2011 and June 2011. Use: The Inspira AIR Balloon Dilation System is an airway balloon catheter intended to dilate and restore airflow to a patient’s airways. Recalling Firm: Acclarent, Inc….
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…
Information on Silicone Gel-Filled Breast Implants (Added Sientra?s Silicone Gel Breast Implants
Description: Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells. Silicone gel-filled breast implants are approved for breast augmentation in women age 22 or older and for breast reconstruction in women of any age. They are also…