J&J’s Computer-Assisted Sedation System Gets FDA Panel Nod
This article was originally published in The Gray Sheet
Executive Summary
Ethicon Endo-Surgery's Sedasys computer-assisted personalized sedation system should be approved by FDA, as long as labeling requires a three-person team to be present during its use, according to the agency's Anesthesiology and Respiratory Therapy Devices panel
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J&J Gets Second Chance At Sedasys Sedation Device Approval
Johnson & Johnson subsidiary Ethicon Endo-Surgery has received a go-ahead from the FDA commissioner's office to embark on a rarely used process to appeal a PMA denial by the agency’s device center.
J&J Gets Second Chance At Sedasys Sedation Device Approval
Johnson & Johnson subsidiary Ethicon Endo-Surgery has received a go-ahead from the FDA commissioner's office to embark on a rarely used process to appeal a PMA denial by the agency’s device center.