A Medical Device Daily
Thoratec (Pleasanton, California) said Wednesday that an FDA administration advisory panel will review later this year its application seeking approval for its HeartMate II, an implantable device used on advanced-stage heart failure patients, as a bridge to transplants.
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 Nov. 30, 2007.
Recently, the company reported it had filed an amendment to its premarket approval (PMA) application the week of July 23 that it believed addressed all of the significant deficiencies outlined by the FDA in its comment letter. The company also reported that it has now responded to all outstanding questions raised in the FDA’s comment letter.
Thoratec makes therapies to address advanced stage heart failure.