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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 SYSTEM
Classification Namestent, carotid
ApplicantCORDIS CORP.
PMA NumberP030047
Supplement NumberS012
Date Received02/06/2008
Decision Date09/10/2008
Product Code
NIM[ Registered Establishments with NIM ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the incoming inspection specifications for the raw material used for the hypotube component.
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