Pression Submits 510(k) to FDA

Pression submitted its 510K to FDA on March 12 and they confirmed the submission was complete on March 25. The first substantive interaction we expect from FDA for this submission is questions and clarifications about the information submitted. FDA has the option of stopping the review clock when they send us their request or allowing it continue running. If they decide to stop the clock, it will resume as soon as we provide a response and will extend their decision date by that many days.

Currently, we are expecting that first interaction on or around May 9. Assuming no stopping of the clock, our final decision date is estimated to be June 10. We remain confident in the strength of the results of our clinical trial and the quality of the reports and analyses performed on our system’s hardware. With that in mind, we are proceeding ahead with starting up our production processes in earnest with the expected positive outcome.