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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device ingestible event marker
Definition To provide confirmation of an event co-ingested or coincident with the ingestible component of the device. The wearable component of the device incorporates wireless communication to display the event and other information on a general computing device
Product CodeOZW
Regulation Number 880.6305
Device Class 2


Premarket Reviews
ManufacturerDecision
ETECTRX, INC.
  SUBSTANTIALLY EQUIVALENT 1
OTSUKA AMERICA PHARMACEUTICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROTEUS BIOMEDICAL, INC.
  GRANTED 1
PROTEUS DIGITAL HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2018 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 2 2

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