The FDA has recently approved the following devices to be marketed:
ZOLL® X Series®, R Series®, AED Pro®, and AED 3 BLS® Professional Defibrillators
The ZOLL® X Series®, R Series®, AED Pro®, and AED 3 BLS® are defibrillators intended to deliver lifesaving electrical shocks to people experiencing sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating.
PREVELEAK Surgical Sealant
PreveLeak Surgical Sealant (PreveLeak) is a medical sealant used to help stop leaks that are formed in tissue, blood vessels or grafts (artificial blood vessels) during the surgical repair of the circulatory system. PreveLeak is a liquid made of two components, purified bovine serum albumim (BSA) and polyaldehyde. The two components are contained in separate barrels of a syringe. Upon mixing these two components, a flexible material is formed.
