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

Cardima

This article was originally published in The Gray Sheet

Executive Summary

CDRH officials tell Cardima at a June 18 meeting that a new randomized clinical trial of the Revelation Tx ablation catheter will be necessary to earn approval for an atrial fibrillation indication. The meeting was prompted by a May 28 non-approvable letter rejecting the firm's initial application for the second time (1"The Gray Sheet" June 7, 2003, p. 10)...
Advertisement

Related Content

Cardima, Nasdaq make amends
Cardima Revelation Tx Receives Second Rejection Letter, May Need New Data
Cardima Revelation Tx Receives Second Rejection Letter, May Need New Data
Advertisement
UsernamePublicRestriction

Register

MT020494

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