FDA-Device2017-09-20Class II
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable
Boston Scientific Corporation
Hazard
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Sold states
US Distribution to one customer in Missouri.
Affected count
3
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they can be displayed on and/or recorded in a receiving device (iLab POLARIS Multi-Modality Guidance System or other monitoring device). The physiological signals can also be distributed by cable
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3132-2017Don't want to check this manually?
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