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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.
 
DeviceENDURANT STENT GRAFT SYSTEM, ENDURANT II STENT GRAFT SYSTEM, ENDURANT II'S STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Place
Santa Rosa, CA 95403
PMA NumberP100021
Supplement NumberS049
Date Received08/10/2015
Decision Date09/11/2015
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT00870051
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
INTRODUCTION OF A MANUFACTURING AID DURING THE DELIVERY SYSTEM EXTERNAL HANDLE ASSEMBLY PROCESS.
Post-Approval StudyShow Report Schedule and Study Progress
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