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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 NameCARTOID WALLSTENT MONORAIL ENDOPROSTHESIS
Classification Namestent, carotid
Generic Namestent,carotid
ApplicantBOSTON SCIENTIFIC
PMA NumberP050019
Supplement NumberS008
Date Received07/15/2011
Decision Date01/27/2012
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 modifications to the labeling to include the post-approval study findings.
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