In Brief: Ventritex
This article was originally published in The Gray Sheet
Executive Summary
Ventritex: Anticipates submission of an investigational device exemption application to FDA in the fourth quarter to begin a study of an "active can" version of its Cadet implantable defibrillator, Ventritex President and CEO Frank Fischer tells a Sept. 20 session of the Bear Stearns health care conference in New York City. A premarket approval application supplement for the pectorally implantable Cadet was sent to FDA in June. Fisher notes that the company also plans to submit an IDE application in the fourth quarter for a single lead transvenous lead system. Ventritex submitted a PMA supplement for its TVL two lead system in June ("The Gray Sheet" July 10, p. 15)
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