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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 NameCORDIS PRECISE NITINOL STENT
Classification Namestent, carotid
ApplicantCORDIS CORP.
PMA NumberP030047
Supplement NumberS009
Date Received11/21/2007
Decision Date04/14/2008
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 studies findings.
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