The Food and Drug Administration has notified U.S. Surgical thatit will allow the Norwalk, CT, company to continue to market itsAdvanced Breast Biopsy Instrumentation (ABBI) device under theproduct's existing 510(k) application. The FDA issued a
The Food and Drug Administration has notified U.S. Surgical that
it will allow the Norwalk, CT, company to continue to market its
Advanced Breast Biopsy Instrumentation (ABBI) device under the
product's existing 510(k) application. The FDA issued a warning
letter to U.S. Surgical last month, claiming that ABBI's 510(k)
application did not include an indication for breast biopsy (SCAN
6/19/96). U.S. Surgical denied the FDA's claims. The two sides
are in negotiations to resolve any remaining issues related to
ABBI advertising and labeling, according to the company.
