RelayPro Thoracic Stent-Graft System

FDA Premarket Approval P200045 S001

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.

Pre-market Approval Supplement Details

Approval of the protocol for the relaypro post approval surveillance study. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p200045.

DeviceRelayPro Thoracic Stent-Graft System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantBolton Medical, Inc.
Date Received2021-09-03
Decision Date2021-11-16
PMAP200045
SupplementS001
Product CodeMIH 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination Product No
Applicant Address Bolton Medical, Inc. 799 International Parkway sunrise, FL 33325

Supplemental Filings

Supplement NumberDateSupplement Type
P200045Original Filing
S001 2021-09-03 Normal 180 Day Track No User Fee

NIH GUDID Devices

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