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Propofol Device Maker, Ethicon Endo-Surgery, Inc., Settles Dispute With FDA



12/1/2011 8:06:44 AM

Ethicon Endo-Surgery, a division of Johnson & Johnson, has reached a settlement with the FDA, which had denied approval of its sedation device Sedasys, and has withdrawn its request to go before a dispute resolution panel in December, according to a statement from the company. Sedasys is a computer-assisted sedation system that allows doctors or nurses to provide minimal-to-moderate sedation with propofol during colonoscopy and endoscopy of the upper gastrointestinal tract in healthy adults.

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