FDA considers pump classification

12/10/2012 | CardiovascularBusiness.com

In federal testimony on behalf of SCAI, Dr. George Vetrovec expressed support for use of the nonroller pump for left ventricular support and percutaneous coronary intervention. An FDA panel voted last week that nonroller type cardiopulmonary bypass blood pumps should remain Class III devices, meaning that if the FDA follows the recommendation, manufacturers will have to prepare premarket approval documents. Vetrovec said that could pose a hardship for small manufacturers and divert resources from innovation.

View Full Article in: