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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adjunctive epicardial vascular physiologic status indicator
Definition The adjunctive epicardial vascular physiologic status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting the possible presence of functionally significant coronary artery disease to suggest the need for further testing. This device is intended for adjunctive use with other clinical workup or patient information and is not intended to quantify the degree to which epicardial disease is limiting flow through a vessel nor is it intended to independently direct therapy.
Product CodeQXZ
Regulation Number 870.2200
Device Class 2


Premarket Reviews
ManufacturerDecision
CLEERLY, INC
  SUBSTANTIALLY EQUIVALENT 1

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