FDA has recently approved the following devices to be marketed:
PulseRider Aneurysm Neck Reconstruction Device (“PulseRider”) – H160002
The PulseRider is a permanent nitinol (nickel titanium) self-expanding stent implant for the treatment of wide-necked aneurysms located at or near branching areas of arteries in the brain. The device’s Y or T shape provides support for the placement of neurovascular embolic coils (flexible strands of thin coiled wire that assist clot formation within an aneurysm) and hold them in place inside the aneurysm.
LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger – P160012
The LIFEPAK CR Plus and LIFEPAK EXPRESS are portable, battery operated, public access defibrillators designed to treat people experiencing sudden cardiac arrest (SCA) a medical condition in which the heart suddenly and unexpectedly stops beating.
MiniMed 630G System with SmartGuard – P150001/S021
The Medtronic MiniMed 670G System with SmartGuard is a hybrid closed loop system that monitors glucose and automatically adjusts the delivery of long acting or basal insulin based on the user’s glucose reading. This device was approved on June 2, 2017 under P150001/S008. The current approval adds a new indication to insert the sensor into the patients’ the upper arm.
MiniMed 670G System – P160017/S017
The MiniMed 670G System is a hybrid closed loop system that monitors glucose and automatically adjusts the delivery of long acting or basal insulin based on the user’s glucose reading. This device was approved on September 28, 2016 under P160017. The current approval adds a new indication to insert the sensor into the patient’s upper arm.
