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BRIEF-Pulse Biosciences announces withdrawal and planned resubmission of 510(k) application for the PulseTxTM System
2017年9月11日 / 中午12点12分 / 15 天前

BRIEF-Pulse Biosciences announces withdrawal and planned resubmission of 510(k) application for the PulseTxTM System

Sept 11 (Reuters) - Pulse Biosciences Inc

* Pulse Biosciences Inc - “‍remain confident” in ability to obtain a 510(k) clearance for PulseTx System and more broadly for Nano-Pulse Stimulation​

* Pulse Biosciences - withdrawal was result of FDA’s appropriate request for additional data that could not be provided within 90-day review period​

* Pulse Biosciences Inc - ‍plans to submit supplemental information in a subsequent 510(k) application in coming months​ Source text for Eikon: Further company coverage:

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