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In Brief: U.S. Surgical Abbi

This article was originally published in The Gray Sheet

Executive Summary

U.S. Surgical Abbi: USSC will provide clinical data to FDA on its Abbi minimally invasive breast biopsy system in an ongoing effort to convince the agency to allow marketing of the device under its current 510(k). U.S. Surgical says it expects a "positive" outcome to the discussions and notes that it can continue selling the device pending resolution of the issue. The firm announced June 4 that FDA had indicated it may have made an error in issuing the 510(k) and was considering rescinding the premarket notification clearance ("The Gray Sheet" June 10, I&W-10). USSC also is holding discussions with the agency to resolve outstanding labeling and advertising issues regarding the Abbi system raised in a June 3 warning letter to the company...

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