August 15, 2007 - Thoratec Corp., 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.
For more information: www.thoratec.com or www.itcmed.com