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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.
 
DeviceENROUTE TRANSCAROTID STENT SYSTEM
Generic Namestent, carotid
ApplicantSILK ROAD MEDICAL, INC
1213 innsbruck drive
sunnyvale, CA 94089
PMA NumberP140026
Supplement NumberS002
Date Received03/07/2016
Decision Date07/19/2016
Product Code NIM 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the following changes to the post-approval study for the device: editorial, protocol, exclusion changes, as well as verbage changes.
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