December 29, 2005

FDA has issued an update to the July and October, 2005, Preliminary Public Health Notification (PPHN), "Guidant VENTAK PRIZM(r) 2DR and CONTAK RENEWAL(r) and RENEWAL(r) 2 Implantable Cardioverter Defibrillators. The updated PPHN provides numbers of deaths and serious injuries for the three devices as of December 12, 2005. FDA's recommendations have not changed.

The PPHN can be found at http://www.fda.gov/cdrh/safety/122805-guidant.html