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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 RX NITINOL STENT SYSTEM
Classification Namestent, carotid
ApplicantCORDIS CORP.
PMA NumberP030047
Supplement NumberS010
Date Received12/17/2007
Decision Date01/16/2008
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the manufacturing materials for the processing aid, which is used to tack the support member sleeve in place while the sleeve is heat-shrunk over the entire assembly.
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