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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
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
3910 Brickway Blvd.
Santa Rosa, CA 95403
PMA NumberP120006
Supplement NumberS024
Date Received03/18/2016
Decision Date09/29/2016
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for manufacturing sites located at Synergy Health AST, LLC, 9020 Activity Road Suite D, San Diego, California 92126 and Synergy Health AST, LLC, 3200 Lakeville Highway, Suite 120, Petaluma, California 94954, for E-Beam sterilization of the Ovation Abdominal Stent Graft System Platform.
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