FDA Dispute Panel Rebuffs Cardima’s Catheter A-Fib Claims
This article was originally published in The Gray Sheet
Executive SummaryAn 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
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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.
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.