Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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 As a result, the company has withdrawn a formal appeal of FDA’s prior denial of the Sedasys PMA and FDA has agreed to re-review the pre-market submission.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT030781

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel