Telectronics Guardian ATP2 ICD could get panel review this year, company says.
This article was originally published in The Gray Sheet
Executive Summary
TELECTRONICS GUARDIAN ATP2 IMPLANTABLE DEFIBRILLATOR FDA PANEL REVIEW could occur later this year, the company says. Telectronics is hoping that a premarket approval application for its second-generation implantable cardioverter defibrillator will be reviewed by FDA's Circulatory System Devices Advisory Panel at a meeting scheduled for late August. The company submitted the PMA to FDA last summer.