Coronary Stent

FDA approves extension of expiration date for TAXUS Express2 stent system

Published in Medical Letter on the CDC and FDA, September 19th, 2004

Boston Scientific Corp. (BSX) announced that the U.S. Food and Drug Administration (FDA) has approved extending the shelf life of its TAXUS Express2 paclitaxel-eluting coronary stent system in the United States to 9 months from the current shelf life of 6 months.

The decision was based on data submitted by Boston Scientific to the FDA that demonstrated the performance of the TAXUS system - in particular the drug content, drug-degradation profile, and drug-release mechanism - was maintained within FDA-approved specifications at 9 months.

The extended expiration date applies to all sizes of the TAXUS system for sale in the United States. The company...

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Source: Medical Letter on the CDC and FDA (2004-09-19)

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