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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.
 
DeviceVALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP100040
Supplement NumberS021
Date Received05/20/2015
Decision Date10/30/2015
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT00413231
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR AN UPDATE TO THE VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM¿S INSTRUCTIONS FOR USE (IFU) TO INCLUDE THE VALOR II POST APPROVAL STUDY DATA.
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