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FDA issues "not approvable" letter for amended silicone gel breast implant PMA.
2004 FEB 5 - (NewsRx.com & NewsRx.net) -- Inamed Corp. (IMDC), has received a "Not Approvable" letter from the U.S. Food and Drug Administration (FDA).
The letter outlines the additional information that Inamed must provide prior to the FDA's further review of its premarket approval application (PMA) for silicone gel-filled breast implants. According to the letter, submission of this requested information and data will place the PMA in approvable form and allow the FDA to conduct further review of Inamed's PMA.
"Although we are disappointed with the current outcome, we appreciate the serious and thorough review of our PMA by the Food and Drug Administration," said Nick ...
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Source: HighBeam Research, FDA issues "not approvable" letter for amended silicone gel breast...