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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140025 added)
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Implanted Blood Access Devices for Hemodialysis
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Meeting Notice: March 15-16, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
Food and Drug Administration [Docket No. FDA-2015-N-0001] Circulatory System 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 meeting will be open to the public. Name…
Updates to Anaplastic Large Cell Lymphoma (ALCL) webpage
In 2011, the FDA identified a possible association between breast implants and the development of anaplastic large cell lymphoma (ALCL), a rare type of non-Hodgkin’s lymphoma. At that time, the Agency was aware of approximately 60 cases of ALCL in women with breast implants, out of approximately 5-10 million women who had received breast implants…
Postmarket Management of Cybersecurity in Medical Devices
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Class I Medical Device Recall: Brainlab Cranial Image-Guided Surgery (IGS) System – Navigation Inaccuracy
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Program Book
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Summary Information for: KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM)
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