|Trade Name||PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM|
|Classification Name||stent, carotid|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: sterilization|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change to the manufacturing process: 1) to include an alternate three(3)-pallet sterilization chamber and 2) to reduce the frequency of pyrogen testing.