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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 NamePRECISE NITINOL STENT SYSTEM/PRECISE RX NITINOL STENT SYSTEM/PRECISE PRO RX NITINOL STENT SYSTEM
Classification Namestent, carotid
ApplicantCORDIS CORP.
PMA NumberP030047
Supplement NumberS016
Date Received12/03/2008
Decision Date12/24/2008
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to incorporate an additional precaution into the instructions for use to address the potential for stent fractures that may occur with self-expanding stents such as the cordis precise stent systems.
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