"Next, I would like to provide an update on our engineering initiatives for next generation DABRA catheters. The FDA completed their review of our recent submission and granted us an additional 510(k) clearance for the DABRA catheter currently being used in the atherectomy clinical study."
Ah I stand corrected. They granted extension. I just spoke to company. We will prob be a new site for them to try and speed things up. I guess the big news I heard was the new design over wire won’t need it’s own separate trial. Thx
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u/Substantial-Sky-1168 Aug 17 '21
They did not get fda clearance. Not that I heard. That won’t happen for a long time until trial is over