FDA To Re-Open J&J’s Rejected Sedasys PMA Without Dispute Panel Input
This article was originally published in The Gray Sheet
Executive Summary
J&J/Ethicon Endo-Surgery and FDA say they have come to an understanding over the firm’s Sedasys computer-assisted personalized sedation system. As a result, the company has withdrawn a formal appeal of FDA’s prior denial of the Sedasys PMA and FDA has agreed to re-review the pre-market submission.