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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, peripheral nerve, non-implanted, for urinary incontinence
Regulation Description Nonimplanted, peripheral electrical continence device.
Product CodeNAM
Regulation Number 876.5310
Device Class 2


Premarket Reviews
ManufacturerDecision
AVATION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXODUS INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2 2
2023 3 3
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Emits Odor 2 2
Migration or Expulsion of Device 1 1
Output Problem 1 1
Patient-Device Incompatibility 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 2 2
Undesired Nerve Stimulation 1 1
Pain 1 1
Convulsion/Seizure 1 1
Urinary Incontinence 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

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