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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device integrated continuous glucose monitor for non-intensive glucose management, over-the-counter
Definition An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose management is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels across the range spanning clinically significant hypoglycemia and hyperglycemia levels in persons who are not on insulin and who do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose management are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices.
Product CodeSBH
Regulation Number 862.1355
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT DIABETES CARE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 1 1

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