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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 RX CAROTID STENT SYSTEM
Classification Namestent, carotid
ApplicantEV3 INC
PMA NumberP060001
Supplement NumberS017
Date Received08/21/2012
Decision Date02/12/2013
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the create post- approval study (pas) results to the instructions for use (ifu).
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