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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 prior to labor
Regulation Description Hygroscopic Laminaria cervical dilator.
Definition Mechanical dilation of the cervical canal for labor.
Product CodePFJ
Regulation Number 884.4260
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material rupture 4
No Known Device Problem 3
Device operates differently than expected 1
Total Device Problems 8

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon, Inc. II Jan-06-2016

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