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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 NumberS003
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 bio-inert filler ingredient that is primarily used as a thickening agent for the uv adhesive.
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