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U.S. Surgical Abbi breast biopsy system's revised 510(k) clearance contraindicates therapeutic use.

This article was originally published in The Gray Sheet

Executive Summary

U.S. SURGICAL ABBI BREAST BIOPSY SYSTEM'S SECOND 510(K) CLEARANCE resolves all outstanding regulatory issues with FDA, the firm states in a Dec. 26 release. The clearance, which "supersedes" an original 510(k) issued in February 1996, includes revised labeling stating explicitly that the system is not intended for therapeutic applications, USSC states. The new 510(k) also incorporates new safety and efficacy data on 312 patients to support the previously cleared use of the device as a diagnostic tool in performing minimally invasive breast biopsies.
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