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Gel-filled breast implants approved as class III medical devices in the E.U.
2004 JAN 1 - (NewsRx.com & NewsRx.net) -- Inamed Corp. (IMDC), a global healthcare company, announced the single lumen models of its silicone gel-filled breast implants have been certified as satisfying the European Union's (E.U.) safety and efficacy requirements for the most stringent classification, Class III medical device, months ahead of the March 1, 2004, deadline to continue sales.
"These implants were reclassified by the E.U. into the strictest category of medical devices for sale to the public," said Nick Teti, chairman, CEO, and president of Inamed. "We are gratified that these products have been determined by scientific review in the EU to be safe and ...
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