PLEASANTON, Calif., Aug. 15 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, said today that its PMA (PreMarket Application) seeking approval of its HeartMate II for bridge-to-transplantation will undergo review by an FDA advisory panel later this year.
The company said that it has been informed by the FDA that the tentative date for the review by a Circulatory Systems Device Advisory Panel is November 30, 2007.
Recently, the company announced it had filed an amendment to its PMA the week of July 23rd that it believed addressed all of the significant deficiencies outlined by the FDA in its comment letter. The company also announced that it has now responded to all outstanding questions raised in the FDA's comment letter.
Thoratec is a world leader in therapies to address advanced stage heart failure. The company's product lines include the Thoratec VAD(R) (Ventricular Assist Device) and HeartMate LVAS (Left Ventricular Assist System) with more than 11,000 devices implanted in patients suffering from heart failure. Additionally, its International Technidyne Corporation (ITC) division supplies blood testing and skin incision products. Thoratec is headquartered in Pleasanton, California. For more information, visit the company's websites at http://www.thoratec.com or http://www.itcmed.com.
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not exclusively those addressing future performance or timelines and
milestones for clinical trials within the meaning of Section 27A of the
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|SOURCE Thoratec Corporation|
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