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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
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.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 2
ENTELLUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
FIAGON GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC XOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPIGGLE & THEIS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 4 4
2018 2 2
2019 1 1
2020 2 2
2021 1 1
2022 3 3
2023 4 4
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 8 8
Patient Device Interaction Problem 5 5
Material Rupture 2 2
Burst Container or Vessel 2 2
Pressure Problem 1 1
Crack 1 1
Material Fragmentation 1 1
Insufficient Information 1 1
Bent 1 1
Contamination of Device Ingredient or Reagent 1 1
Product Quality Problem 1 1
Appropriate Term/Code Not Available 1 1
Protective Measures Problem 1 1
Unsealed Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Discomfort 3 3
Hearing Impairment 2 2
Inflammation 2 2
Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Syncope/Fainting 1 1
No Information 1 1
Vascular Dissection 1 1
Dizziness 1 1
Itching Sensation 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Ear or Labyrinth Problem 1 1
Insufficient Information 1 1
Bradycardia 1 1
Asystole 1 1
Unspecified Tissue Injury 1 1
Tissue Damage 1 1
No Consequences Or Impact To Patient 1 1

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