June 15, 2015 Dear Transplant Surgeons and Cardiologists, We are writing to inform you that we have received preliminary information suggesting a higher mortality rate for one subgroup of patients using SynCardia Systems, Inc.’s Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System). Interim analyses suggest that patients who required pre-implant circulatory rescue…

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The Food and Drug Administration (FDA) is announcing a public meeting on the reauthorization of the medical device user fee program. The current legislative authority for the medical device user fee program expires in September 2017 and new legislation will be required for FDA to continue collecting user fees for the medical device program. Date,…

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This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name:  Dexcom G4 PLATINUM (Pediatric) Continuous…

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Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.