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U.S. Surgical allowed to market ABBI

Article

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.

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