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ImpediMed Submits FDA 510(k) Application for SOZO for Lymphoedema

17 Jul 2017  |  09:12:00  |  Associate analysts  |  Increase  |  Decrease  |  

Original announcement: IPD Submits FDA 510(k) Application for SOZO for Lymphoedema

ImpediMed announced the submission of a premarket notification 510(k) application for SOZOTM to the US Food and Drug Administration (FDA) to aid in the clinical assessment of lymphoedema. The submission uses the Company's current medical device, the L-Dex U400, as a predicate. The L-Dex U400 obtained its most recent FDA clearance in June of 2013.

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