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BRIEF-Pavmed says has received a letter from FDA regarding its portio intraosseous infusion system​
October 3, 2017 / 9:42 PM / 16 days ago

BRIEF-Pavmed says has received a letter from FDA regarding its portio intraosseous infusion system​

Oct 3 (Reuters) - Pavmed Inc

* Pavmed Inc - has received a letter from food and drug administration regarding its portio intraosseous infusion system​

* Pavmed Inc - co has decided to follow fda s encouragement and pursue a de novo classification for portio under a broader indication, for up to 7 days​

* Pavmed - ‍ after pursuing de novo classification for portio under a broader indication, co intends to immediately pursue pre-submission meeting with FDA​

* Pavmed - ‍fda determined that portio is not substantially equivalent to proposed predicate

* Pavmed says ‍FDA encouraged company to pursue classification under section 513(f)(2) of federal food, drug, and cosmetic act​ - SEC Filing Source text: (bit.ly/2wvxsUh) Further company coverage:

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