Home » Medtronic Provides Update on Endeavor Stent Program
Medtronic Provides Update on Endeavor Stent Program
Medtronic has received an update regarding the status of its application for CE mark approval of its Endeavor drug-eluting coronary stent.
Medtronic was informed by European regulatory authorities that the device portion of the review has been completed, but that regulatory authorities have issued a few clarifying questions about the drug used to coat the experimental Endeavor stent. The drug compound, ABT-578, is made by Abbott Laboratories.
The company anticipates CE mark approval upon the resolution of these few remaining regulatory questions. The European regulatory authorities did not provide a specific timeline for completing their final review.
KEYWORDS FDAnews Device Daily Bulletin
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