Abiomed says it's come to an agreement with the FDA on an indication for its flagship Impella 2.5 heart pump, and now expects to win pre-market approval early next year without a hearing before an FDA advisory panel.
News Well, MassDevice.com Earnings Roundup, 2014, Cardiac Assist Devices, Pre-Market Approval (PMA), Q3, Regulatory/Compliance
from MassDevice - FDA and Medical device business news and jobs for the medical device industry http://www.massdevice.com/news/abiomed-jumps-fda-deal-impella-indication
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