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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 NumberS002
Date Received07/19/2010
Decision Date02/15/2011
Product Code
NIO[ Registered Establishments with NIO ]
Advisory Committee Cardiovascular
Clinical Trials NCT00730730
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 120mm length complete se vascular stent.
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