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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
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
GTIMD, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Uterine Perforation 3 3

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