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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 NumberS025
Date Received07/20/2016
Decision Date08/17/2016
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Implementation of a revised welding program and modification to the weld flange orientation which is used in the manufacturing of the Ovation Abdominal Stent Graft System.
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