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Re: None

Tuesday, 01/06/2015 2:38:47 PM

Tuesday, January 06, 2015 2:38:47 PM

Post# of 4523
From flare9x on Sheff's board. Post #85047

ETRM - 1.36 -- Submits PMA June 25th: http://ir.enteromedics.com/releasedetail.cfm?releaseid=773470

FDA PMA Review Process: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm047991.htm


From FDA website: The 180-day period for review of a PMA starts on the date of filing.

For ETRM this 180 period starts from June 25th... almost 6 months from June 25 is about the Dec 25th period date....