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Consumer Information on: ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems)
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Summary Information for: ION? Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Delivery Systems)
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Summary Information for: PROGENSA® PCA3 Assay
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Consumer Information on: Breast Companion® Software System
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Summary Information for: Breast Companion® Software System
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Comunicado de la FDA sobre la seguridad de los medicamentos: Cambios importantes en la etiqueta de seguridad de los medicamentos para reducir el colesterol conocidos como estatinas
Anuncio de seguridadInformación adicional para pacientesInformación adicional para profesionales de la saludResumen de datosLimitaciones en la dosis de lovastatinaReferencias Anuncio de seguridad El 28 de febrero del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) aprobó importantes cambios a la etiqueta de seguridad en un tipo de…
Summary Information for: Ovation Abdominal Stent Graft System
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Consumer Information on: OVATION Abdominal Stent Graft System
FDA approved this device under the Humanitarian Device Exemption (HDE) program. See the links below to the Summary of Safety and Probable Benefit (SSPB) and other sites for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: OVATION Abdominal Stent Graft System Manufacturer: Trivascular, Inc. Address:…
Class I Medical Device Recall: Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs)
Recall Class: Class I Date Recall Initiated: January 13, 2012 Products: Cardiac Science Powerheart, CardioVive, and CardioLife Models of AEDs GE Responder and Responder Pro AEDs Nihon-Kohden AEDs Affected Models: Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E; CardioVive 92532, 92533; CardioLife 9200G and 9231; GE Responder and Responder Pro; and Nihon-Kohden AEDs Go to Serial…