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www.fdanews.com/articles/151170-dune-medical-devices-receives-fda-approvable-letter-for-marginprobe-system

Dune Medical Devices Receives FDA Approvable Letter for MarginProbe System

November 20, 2012
Officials at Dune Medical Devices announced the company received an Approvable Letter for its Premarket Approval Application from the FDA. The Approvable Letter states that the MarginProbe System PMA is approvable subject to final agreement with FDA on the design of the required Post Approval Study.
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