FDA commissioner: Ethicon appeal of PMA rejection moves forward

March 21, 2011 by MassDevice staff

FDA commissioner Margaret Hamburg green-lights a new review of a gastro-enterology procedure sedation system made by Johnson & Johnson's Ethicon Endo-Surgery division, which was denied a PMA last year.

Ethicon Endo-Surgery logo

Ethicon Endo-Surgery Inc. has been granted another review of its Sedasys System by the office of the FDA commissioner, a potential victory for the Johnson & Johnson (NYSE:JNJ) subsidiary and its appeal of the agency's PMA denial for its sedation system for gastro-enterology procedures.

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