Monroe Medical Device Consulting LLC
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Boston Scientific

Monroe Medical Device Consulting has assisted Boston Scientific recently received clearance of their device K151613, ILab Polaris Multi-Modality Guidance System, an Intravascular Ultrasound Imaging System, featuring its imaging modality, Fractional Flow Reserve (FFR).

The FDA in its assessment of the responses to their additional questions stated: "'Our expert software consultant on the submission thought that you and your team did such a great job at addressing the questions contained in our Additional Information request, that he has forwarded your responses to the “Cardiac Diagnostic Devices Branch Hall of Fame” to serve as a prime example of a comprehensive response to concerns such as the Cybersecurity and Interoperability of devices, among others.'"

The work Monroe Medical Device Consulting has done with us has been invaluable in helping us to achieve our goal.

Dan Krause, MSc.

Boston Scientific
Regulatory Affairs
Interventional Cardiology - PCI Guidance