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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 NamePROTÉGÉ GPS AND PROTÉGÉ RX CAROTID STENT SYSTEMS
Classification Namestent, carotid
ApplicantEV3 INC
PMA NumberP060001
Supplement NumberS007
Date Received05/27/2008
Decision Date06/26/2008
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Move manufacturing of a component in-house and add an alternate tent compaction method.
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