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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 NameCOMPLETE SE VASCULAR STENT SYSTEM
Classification Namestent, iliac
Generic Nameiliac stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP090006
Supplement NumberS003
Date Received11/26/2010
Decision Date01/14/2011
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate sterilization site located in offaly, ireland.
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