FDA sets date to review Boston Scientific stent

The Food and Drug Administration will hold a special panel hearing on November 20 to review Boston Scientific’s premarket approval (PMA) application for the Taxus Express2 paclitaxel-eluting coronary stent. The Natick, MA-based interventional device developer said it presented the fifth and final module of the product’s PMA to the FDA this June, an action that marked the beginning of the official regulatory review process for the device.

By AuntMinnie.com staff writers
September 16, 2003

Related Reading

Boston Scientific releases Taxus clinical results, September 16, 2003

Boston Scientific’s Taxus stent receives Canadian approval, September 12, 2003

Boston Scientific, CryoVascular form alliance, September 11, 2003

Boston Scientific adds to IVUS offerings, August 14, 2003

Boston Scientific seeks stock split, July 30, 2003

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