Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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


FDA Dispute Panel Rebuffs Cardima’s Catheter A-Fib Claims

This article was originally published in The Gray Sheet

Executive Summary

An FDA dispute resolution body all but halted Cardima's chances to turn around the fortunes of its Revelation Tx microcatheter NavAblator ablation system April 19, voting 5-0 not to recommend approval of the product

You may also be interested in...

Regulatory Roundup: FDA Panels; Proteomics; Experiential Learning; 510(k)s

FDA has officially scheduled the first meeting of its Medical Devices Dispute Resolution Panel in more than seven years to assess the case of FzioMed Inc.’s PMA for the Oxiplex gel for lumbar spine surgery. An ophthalmic devices panel has been set for a new corneal implant, and more regulatory news.

FzioMed Gets Second Chance For Oxiplex Gel PMA With Dispute Resolution Panel

FDA granted FzioMed’s petition for an independent review of its Oxiplex gel PMA by the Medical Devices Dispute Resolution Panel in response to FzioMed’s November 2012 petition. The agency deemed the device, intended for use in spine surgery, as “not approvable” in 2008.

J&J Gets Panel Date Seeking First A-Fib Ablation Catheter Indication

Johnson & Johnson's chances of becoming the first firm to market an ablation device in the U.S. labeled for treating atrial fibrillation will be clearer next month, when the company is scheduled to present PMA supplement data to an FDA advisory panel

Related Content

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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