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BRIEF-Episurf Medical gets feedback from FDA on 513(g) request
May 15, 2017 / 12:54 PM / 4 months ago

BRIEF-Episurf Medical gets feedback from FDA on 513(g) request

May 15 (Reuters) - EPISURF MEDICAL AB

* EPISURF MEDICAL CONTINUES ITS COMMUNICATION WITH THE US FOOD AND DRUG ADMINISTRATION (FDA) REGARDING APPROPRIATE ROUTE FOR MARKET ACCEPTANCE IN THE US

* EPISURF MEDICAL HAS NOW RECEIVED FEEDBACK FROM FDA REGARDING 513(G) REQUEST

* FEEDBACK IS NOT DECISIVE AND OPENS UP VARIOUS ALTERNATIVES FOR EPISURF MEDICAL TO ASSESS; FURTHER INTERACTION WITH FDA HAS BEEN INITIATED

* COMPANY EXPECTS TO COMPLETE ITS REVIEW AND REACH A DECISION BY Q3 OF 2017 Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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