Recently Approved Devices

Lifeline/ReviveR ECG and DDU Automated Defibrillators - P160032
The LifeLine/ReviveR Public Access Defibrillators (PAD) family of Automated External Defibrillators (AEDs) are portable, battery operated, 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.

Abbott Perclose ProGlide Suture-Mediated Closure System - P960043/S097
The Perclose ProGlide Suture-Mediated Closure System is composed of a plunger, handle, guidewire, and sheath. The device is designed to deliver a single suture (stitch) to close the puncture sites (access sites) in large vessels in the leg (femoral vein or artery) following catheterization procedures. Catheterization procedures are commonly used to observe or treat a disease/condition in blood vessels or in the heart. During these procedures, an opening may be made in the femoral vein or artery to insert a catheter (flexible tube). After the procedure is finished, the catheter is removed. The placement of a suture where the catheter was inserted will prevent blood flow until the access site heals.