FzioMed Gets Second Chance For Oxiplex Gel PMA With Dispute Resolution Panel
This article was originally published in The Gray Sheet
Executive Summary
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.
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