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news.Interventional Spine has announced that the FDA has approved its investigational device exemption application for its PercuDyn System for the treatment of degenerative disc disease.
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This approval is conditional upon the company providing some additional information to the FDA.
Walter Cuevas, CEO of Interventional Spine, said: “We believe that the PercuDyn System is the first and only product of its kind, and we look forward to a day when it can be marketed in the US as it already is in international markets.
“To that end, we now move to the next phase in the FDA approval process in gathering the data required for submission and pre-market approval.”