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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device catheter, balloon, dilation of cervical canal
Regulation Description Hygroscopic Laminaria cervical dilator.
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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