Published on November 20, 2012 at 12:03 AM
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.
"We are delighted to have come to this point in the approval process with FDA and will work diligently over the coming weeks to develop the final design of the Post Approval Study. Having completed our discussions with FDA related to product labeling, the Post Approval Study is the only remaining issue to be resolved prior to final approval," said Daniel Levangie, Chief Executive Officer of Dune Medical Devices.
SOURCE Dune Medical Devices