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