CADENCE/ENDOTAK APPROVAL FOR COMBINATION USE
This article was originally published in The Gray Sheet
Executive Summary
CADENCE/ENDOTAK APPROVAL FOR COMBINATION USE establishes the first commercially available system using a biphasic automatic implantable cardiac defibrillator and transvenous leads. Sunnyvale, California-based Ventritex announced Oct. 28 that it received approval from FDA for a premarket approval supplement, filed in Sept. 1993, to expand the labeling of its Cadence V-100 and V-110 defibrillators to include their use with Cardiac Pacemakers, Inc.'s Endotak 60 and 70 transvenous leads.