www.fdanews.com/articles/89506-fda-approves-proteg-eacute-stents
FDA APPROVES PROTEGÉ STENTS
January 30, 2007
The FDA Jan. 26 posted information on two recently approved stents.
The Protégé GPS and RX carotid stent systems, manufactured by ev3, were approved Jan. 24. The devices are used to reopen stenotic (narrowed) regions of the carotid arteries in the neck, which supply blood to the brain.
The FDA approval letter for the devices can be viewed at www.fda.gov/cdrh/pdf6/p060001a.pdf (http://www.fda.gov/cdrh/pdf6/p060001a.pdf).