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Monday, April 1, 2019

Apyx pulls application for premarket notification 510k submission to FDA

Apyx Medical Corporation announced it has voluntarily withdrawn its application for premarket notification 510k regulatory clearance of J-Plasma/Renuvion for use in dermal resurfacing procedures. The company will continue to work with the U.S. Food and Drug Administration relative to the development of a new 510k submission. At the present time, the company cannot provide a timeline for resubmission but intends to do so after further discussions with the Agency.
https://thefly.com/landingPageNews.php?id=2886991

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