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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 NameS.M.A.R.T NITINOL STENT SYSTEM & CONTROL NITINOL STENT SYSTEM
Classification Namestent, iliac
Generic Nameiliac stent
ApplicantCORDIS CORP.
PMA NumberP020036
Supplement NumberS004
Date Received06/19/2006
Decision Date07/19/2006
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the coining and riveting process of the tantalum microsmarkers to the s. M. A. R. T. Control stent.
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