Warning Letter Close-Outs – July 2021
The resolution of a May 2020 warning letter to a breast implant manufacturer accounted for the only device-related close-out latter issued this month.
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The US agency issued a letter to providers in the wake of a study that found significantly higher complication rates in women implanted with Boston Scientific’s Watchman device.
Virtual and in-person events are planned for Washington, DC, and Minneapolis, MN, during the trade group gathering.
The US patent office has upheld all seven patents at issue, with the verdict on the final three having come on 22 September.