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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, ENDURANT II AORTO-UNI-ILAIAC (AUI) STENT GRAFT SYSTEM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantMedtronic Vascular
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP100021
Supplement NumberS040
Date Received09/03/2014
Decision Date10/03/2014
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF AN ALTERNATE SUPPLIER FOR THE SECONDARY AND TERTIARY PACKAGING FOR ENDURANT AND ENDURANT II STENT GRAFT SYSTEMS. ADDITIONALLY, A CHANGE IN CONFIGURATION FOR THE E-BEAM STERILIZATION PROCESS.
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