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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 AND ENDURANT II STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP100021
Supplement NumberS038
Date Received06/09/2014
Decision Date07/08/2014
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 RADIOPAQUE CONTRALATERAL GATE MARKER INSPECTION OF ENDURANT AND ENDURANT II BIFURCATED STENT GRAFTS AND A COIL DISPENSER AS A VISUAL AID DURING THE PRE-KITTING PROCESS OF ENDURANT II STENT GRAFTS.
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