|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|
|Classification Name||stent, carotid|
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the addition of a new material specification and an incoming inspection step for the annealed tantalum sphere components of the device.