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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.
 
DeviceRelayPro Thoracic Stent-Graft System
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantBolton Medical, Inc.
799 International Pkwy.
Sunrise, FL 33325
PMA NumberP200045
Supplement NumberS001
Date Received09/03/2021
Decision Date11/16/2021
Product Code MIH 
Advisory Committee Cardiovascular
Clinical TrialsNCT02818972
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the RelayPro Post Approval Surveillance Study.
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