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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 NamePROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM
Classification Namestent, carotid
ApplicantEV3 INC
PMA NumberP060001
Supplement NumberS001
Date Received01/29/2007
Decision Date07/17/2007
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product 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.
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