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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 SYSTEMS
Classification Namestent, carotid
ApplicantEV3 INC
PMA NumberP060001
Supplement NumberS011
Date Received02/16/2011
Decision Date03/08/2011
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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