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FDA Panel Wants a Closer Look at St. Jude Medical (STJ) Heart Implant


5/29/2012 9:10:49 AM

An FDA advisory panel recommended taking a closer look at safety data from St. Jude Medical's Amplatzer heart implant, now that more is known about the device after more than a decade on the market. An FDA panel recommended that the agency's Center for Devices & Radiological Health re-analyze existing data for St. Jude Medical's (NYSE:STJ) Amplatzer heart implant during a hearing yesterday to review safety data for the Amplatzer and for W.L. Gore & Associates' Helex implant.

Read at MassDevice
Read at the heart.org

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