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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 NameINTRASTENT DOUBLE STRUT STENT
Classification Namestent, iliac
Generic Namevascular stent
ApplicantEV3 INC
PMA NumberP030045
Supplement NumberS001
Date Received07/18/2005
Decision Date02/28/2006
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at ev3, inc. , plymouth, minnesota and a new sterilization site located at steris isomedix services, inc. Minneapolis, minnesota.
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