Ethicon Endo-Surgery has received official approval from the Food and Drug Administration for an appeal its Sedasys System, a computer-personalized sedation system.
The FDA's official announcement about Sedasys was published in the Federal Register. The FDA intends to refer Ethicon's petition for review of the FDA's denial of premarket approval for review before an advisory committee.
Read the Federal Register notice on Sedasys System.
Read more about Sedasys:
-Johnson & Johnson and FDA Clash Over Rejection of Sedative
-J&J's Ethicon Endo-Surgery Receives Canadian, European Approval for Computer-Assisted Sedation System Rejected by FDA
-ASA Responds to FDA's Rejection of Johnson & Johnson's Computer-Assisted Anesthesia Device
The FDA's official announcement about Sedasys was published in the Federal Register. The FDA intends to refer Ethicon's petition for review of the FDA's denial of premarket approval for review before an advisory committee.
Read the Federal Register notice on Sedasys System.
Read more about Sedasys:
-Johnson & Johnson and FDA Clash Over Rejection of Sedative
-J&J's Ethicon Endo-Surgery Receives Canadian, European Approval for Computer-Assisted Sedation System Rejected by FDA
-ASA Responds to FDA's Rejection of Johnson & Johnson's Computer-Assisted Anesthesia Device