www.fdanews.com/articles/96405-monogen-announces-180-day-pma-supplement-for-new-manufacturing-facility
MonoGen Announces 180-Day PMA Supplement for New Manufacturing Facility
July 27, 2007
MonoGen announced that the FDA has determined the relocation of its manufacturing facility will require a 180-day PMA supplement. The supplement is expected to be filed by the end of this quarter.
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