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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device eustachian tube balloon dilation device
Regulation Description Eustachian tube balloon dilation system.
Definition The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
Product CodePNZ
Regulation Number 874.4180
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCLARENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENTELLUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FIAGON GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPIGGLE & THEIS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 3 3
2023 4 4
2024 9 9
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 7 7
Adverse Event Without Identified Device or Use Problem 4 4
Burst Container or Vessel 2 2
Pressure Problem 1 1
Crack 1 1
Insufficient Information 1 1
Material Fragmentation 1 1
Inflation Problem 1 1
Material Rupture 1 1
Contamination of Device Ingredient or Reagent 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Hearing Impairment 3 3
Discomfort 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Insufficient Information 2 2
Pain 2 2
Bradycardia 2 2
Asystole 2 2
Syncope/Fainting 1 1
Dizziness 1 1
Itching Sensation 1 1
Unspecified Ear or Labyrinth Problem 1 1
Unspecified Tissue Injury 1 1
Swelling/ Edema 1 1

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