dilluns, 9 de març del 2015

Edap bails on Ablatherm PMA, to seek de novo clearance from FDA




Edap says it's bailing out on the pre-market approval bid for its Ablatherm prostate cancer device and plans to seek de novo clearance from the FDA instead.





Edap bails on Ablatherm PMA, to seek de novo clearance from FDA

EDAP TMS SA, Food & Drug Administration (FDA)

News Well, De Novo Clearance, Men's Health, Pre-Market Approval (PMA), Regulatory/Compliance, Urology

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