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semi_infinite

10/14/17 10:07 AM

#214294 RE: semi_infinite #213617

TRXC - +80% AH on FDA 510k clearance. Ahead of schedule that I anticipated.

"FDA concluded that these study data, supported by real-world evidence, along with performance testing under simulated use and worst-case scenario conditions, demonstrated the substantial equivalence of the Senhance System to the da Vinci Si IS3000 device for gynecological and colorectal procedures."