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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, balloon, dilation of cervical canal
Definition Mechanical dilation and softening of the cervix.
Product CodePON
Regulation Number 884.4260
Device Class 2


Premarket Reviews
ManufacturerDecision
CROSSBAY MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GTIMD LLC
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2018 1 1
2019 1 1
2020 3 3
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6 6
Leak/Splash 1 1
Material Rupture 1 1
Detachment of Device or Device Component 1 1
Difficult to Open or Close 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Uterine Perforation 6 6
No Known Impact Or Consequence To Patient 1 1
Chest Pain 1 1
Death 1 1
Respiratory Distress 1 1

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