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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 CAPTIVIA DELIVERY SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP100040
Supplement NumberS022
Date Received05/26/2015
Decision Date06/25/2015
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MANUFACTURING THE VALIANT 17 APEX SINGLE TAA SUPPORT SPRING AT THE MEDTRONIC MEXICO EG MANUFACTURING SITE.
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