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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 & RX NITINOL & PRO RX NITINOL STENT SYSTEM
Classification Namestent, carotid
ApplicantCORDIS CORP.
PMA NumberP030047
Supplement NumberS005
Date Received08/27/2007
Decision Date09/20/2007
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the establishment of an additional specification for a bismuth subcarbonate blend raw material.
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