J&J’s Persistence With Sedasys Pays Off With Approvable Letter

Johnson & Johnson (J&J) subsidiary Ethicon Endo-Surgical received an approvable letter on the Sedasys sedation system, three months after the devicemaker and the FDA reached an accord on an appeal of an earlier no-go decision. An FDA advisory panel recommended Sedasys for approval in June 2009, but the agency sent Ethicon a nonapprovable letter the following October, citing concerns about the computer-assisted propofol delivery device.
Devices & Diagnostics Letter