Dune Medical Devices gets FDA PMA Approvable Letter for MarginProbe System

[News]

Dune Medical Devices, Inc., announced today that it has received an Approvable Letter for its Premarket Approval Application (PMA) from the Food and Drug Administration. 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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