Medical Devices
Medtronic submits final PMA modules to U.S. FDA for drug-eluting coronary stent system
Published in Medical Letter on the CDC and FDA, December 17th, 2006
Medtronic's PMA submission includes safety and efficacy data on approximately 4,100 patients who have been treated with Endeavor in clinical trials that include follow up for as long as 3 years. The data are from the largest, most wide-ranging patient population and for patients with the longest follow-up ever submitted to support the safety and efficacy of a new drug-eluting stent (DES).
Following a PMA submission, the FDA typically...
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