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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 NumberS016
Date Received03/18/2024
Decision Date05/22/2024
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 a manufacturing site Terumo Aortic Glasgow located at Newmains Ave, Inchinnan, Glasgow PA4 9RR, United Kingdom for manufacture of the Delivery System subassembly, loading of the Stent-Graft subassembly onto the Delivery System, and non-sterile packaging of the loaded Delivery System subassemblies of the Bifurcate and Cuff components of the TREO® Abdominal Stent-Graft System
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