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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device gastrointestinal motility system, capsule
Definition Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Product CodeNYV
Regulation Number 876.1725
Device Class 2


Premarket Reviews
ManufacturerDecision
THE SMARTPILL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 2 2
2017 2 2
2019 2 2
2020 1 1
2021 1 1
2022 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 7 7
Adverse Event Without Identified Device or Use Problem 4 4
Unintended Application Program Shut Down 1 1
Patient-Device Incompatibility 1 1
Loss of Data 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 5 5
Radiation Exposure, Unintended 3 3
Abdominal Pain 2 2
Nausea 1 1
Pain 1 1
Urinary Tract Infection 1 1
Vomiting 1 1
Stenosis 1 1
Ulcer 1 1
Unintended Radiation Exposure 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1

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