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Under the agreement, Philips has agreed to continue service until Dec 31, 2022, and it will meet with the TGA twice yearly and report adverse events as required under normal operations. Read More
The software update patches the device’s external USB drive performance and its impact on GUI functionality and labeling displayed on the interface during device use. Read More
All site change supplements should clearly identify any changes to manufacturing locations and associated changes to the manufacturing process that result.
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For reclassification proceedings based on new information and proceedings calling for PMAs for a pre-FDASIA class II device, the agency must convene a classification panel and obtain panel recommendations.
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