Mainstay meets with FDA on ReActiv8 application

‘Day 100’ meeting reviews status of application’s review

Mainstay Medical still expects a decision on ReActiv8 approval by the end of 2020.

Mainstay Medical still expects a decision on ReActiv8 approval by the end of 2020.

 

Medical device company Mainstay Medical has met US regulators as part of its application for market approval for its ReActiv8 implantable device.

The meeting, which is part of the pre-market approval (PMA) application submission, allows the company to discuss the status of the review of the application.

“We appreciate the opportunity to meet with FDA to discuss their review of the data we included in the PMA,” said Jason Hannon, CEO of Mainstay. “The productive dialogue will help us submit an amendment to the PMA to reflect FDA’s feedback.” A decision on approval for the device is expected around the end of 2020.

ReActiv8 is an implantable restorative neurostimulation system designed to treat disabling chronic low back pain.

An amendment to the PMA is expected to be filed in the first quarter of 2020.