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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceANEURX STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 UNOCAL PLACE
SANTA ROSA, CA 95403-1774
PMA NumberP990020
Supplement NumberS040
Date Received06/04/2010
Decision Date07/01/2010
Withdrawal Date 12/20/2013
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO INTRODUCE THE MICROVU MEASUREMENT SYSTEM FOR THE DIMENSIONAL MEASUREMENTS OF EXTRUDED TUBING.
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