FDA OKs independent review of FzioMed's spinal surgery gel

11/5/2013 | MassDevice.com (Boston)

The FDA has authorized an independent review of FzioMed's premarket approval application for Oxiplex, a gel product designed to help lower-back spinal surgery patients heal. The review, which will be conducted by a Medical Devices Dispute Resolution Panel, will consider the case and provide advice to FDA Commissioner Dr. Margaret Hamburg about whether she should reverse the FDA's 2008 decision to refuse the device's PMA.

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MassDevice.com (Boston)

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