Regulatory approvals

July 2008
Cardiovascular Devices & Drugs;Jul2008, Vol. 14 Issue 7, p20
The article reports on several pharmaceutical firms that obtained regulatory approvals for their medical products in June 2008. A CE-mark approval has been given to Global Therapeutics for its new cobalt chromium bare-metal coronary stent. OrbusNeich claimed that it got the approval of Taiwan Department of Health to sell the Genous Bio-engineered R stent in the country. W. L. Gore and Associates has received the regulatory clearance from Japan's Pharmaceuticals and Medical Device Agency (PMDA) to market its Gore TAG Thoracic Endoprosthesis in Japan.


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