FDA and Boston Scientific have issued warning letters for certain Watchman Access Systems updating use instructions for the models. The early alert is part of a pilot program from FDA to enhance ...
The U.S. Food and Drug Administration is warning patients and doctors about possible issues seen with Boston Scientific heart devices. The FDA issued alerts on Aug. 6 about the Marlboro-based ...
The U.S. FDA expanded the approval for use of Boston Scientific Corp.’s Watchman Flx and Watchman Flx Pro left atrial appendage closure (LAAC) devices to include post-ablation patients, bringing good ...
Boston Scientific has secured label expansion from FDA for its Watchman FLX and Watchman FLX Pro. The Marlborough, MA-based company had already expected the label expansion, which now includes ...
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