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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.
Classification Namestent, iliac
Generic Namestent, iliac
6500 paseo padre parkway
fremont, CA 94555
PMA NumberP020036
Supplement NumberS002
Date Received11/24/2003
Decision Date03/19/2004
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following change to the deliver system of the s. M. A. R. T. Control nitinol stent system: 1) the wire lumen of the delivery system will be fabricated from different materials. 2) the new wire lumen inner diameter specification has been increased. 3) the proximal land section of the distal tip has been increased. 4) the inner diameter specification of the distal tip has been increase.