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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 II STENT GRAFT SYSTEM, ENDURANT IIS STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP100021
Supplement NumberS047
Date Received04/14/2015
Decision Date05/06/2015
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR INTRODUCING A LAMP MANDREL AS A MANUFACTURING TOOL FOR THE INSPECTION OF THE RADIOPAQUE CONTRALATERAL GATE MARKER DURING THE MARKER ATTACHMENT PROCESS.
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