483
Microtransponder Inc.FDA 483 - Microtransponder Inc. - March 19, 2026
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Record Details
An FDA inspection of MicroTransponder, Inc. in Lakeway, TX, revealed a failure to submit Medical Device Reports (MDRs) within the required 30-day timeframe. The firm did not report serious injuries, including patient loss of consciousness and seizures, associated with their marketed devices. This indicates a critical deficiency in their post-market surveillance and patient safety reporting procedures.
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