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Article: Non-approvable letter from FDA means further doubt for Cardima.
- Article from:
- Medical Device Daily
- Article date:
- June 2, 2004
CopyrightCOPYRIGHT 2004 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Non-approvable letter from FDA means further doubt for Cardima
A Medical Device Daily Staff Report
Further clouding the status of cardiovascular device manufacturer Cardima (Fremont, California), the company late last week reported receiving a letter from the FDA saying that its premarket approval (PMA) application for the Revelation Tx Microcatheter with NavAblator Ablation System is not approvable.
The turndown was for Cardimas application for use of the system in treating drug-refractory paroxymal atrial fibrillation (AF).
While the company has received a variety of FDA clearances for its ablation systems, in April it issued a ...