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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.
 
DeviceOVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
3910 Brickway Blvd.
Santa Rosa, CA 95403
PMA NumberP120006
Supplement NumberS026
Date Received07/28/2016
Decision Date08/24/2016
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  
Implementation of an update to the iliac stent graft sheath loading fixture configuration and a revision to the corresponding loading process instructions to include the updated fixture configuration; 2) Implementation of the modified maximum loading force specification and in-sheath force specification of the Ovation iX Iliac Limb Stent Graft; and3) Implementation of the modified crimp diameter for the 14 mm Ovation iX Iliac Stent Graft.
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