FDA Accepts ev3's (EVVV) PMA Application for Pipeline Embolization Device
ev3 Inc. (Nasdaq: EVVV) announced that the U.S. Food and Drug Administration (FDA) formally accepted for filing the company's Pre-Market Approval (PMA) application for the Pipeline Embolization Device for treatment of large, giant and wide-necked cerebral aneurysms. The FDA's action means that the PMA application was sufficiently complete and ready for substantive review. The filing date for regulatory purposes is May 18, 2010, the date the FDA received ev3's PMA submission. The FDA also confirmed that the PMA application will receive expedited review and processing.
ev3 estimates that approximately one fourth of worldwide aneurysm treatment procedures could be eligible for treatment with flow diversion devices over the next five years, translating into a market potential of approximately $350 million in 2013.
(NOTE - On June 1, 2010, Covidien PLC (NYSE: COV) agreed to acquire ev3 Inc. in a $2.6 billion cash deal. Covidien will pay $22.50 for each share of ev3)
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ev3 estimates that approximately one fourth of worldwide aneurysm treatment procedures could be eligible for treatment with flow diversion devices over the next five years, translating into a market potential of approximately $350 million in 2013.
(NOTE - On June 1, 2010, Covidien PLC (NYSE: COV) agreed to acquire ev3 Inc. in a $2.6 billion cash deal. Covidien will pay $22.50 for each share of ev3)
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