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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePROTEGE RX CAROTID STENT SYSTEM
Generic NameStent, carotid
ApplicantMedtronic Vascular, Inc.
3033 Campus Dr.
Plymouth, MN 55441
PMA NumberP060001
Supplement NumberS017
Date Received08/21/2012
Decision Date02/12/2013
Product Code NIM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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