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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.
 
DeviceTREO Abdominal Stent-Graft System
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantBolton Medical Inc.
799 International Pkwy
Sunrise, FL 33325
PMA NumberP190015
Supplement NumberS007
Date Received11/23/2020
Decision Date12/16/2020
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
Approval Order Statement  
Approval for a manufacturing site located at Terumo Vietnam Co., Ltd (Lot 44A-B-C, Quang Minh Industrial Zone, Me Linh District, Hanoi City, Vietnam) for kitting and sewing processes of TREO Abdominal Stent Graft.
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