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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device intrauterine tamponade balloon
Regulation Description Obstetric-gynecologic specialized manual instrument.
Definition provides temporary control or reduction of postpartum uterine bleeding
Product CodeOQY
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
CLINICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 2
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 5
Loss of or failure to bond 2
Fluid leak 2
Inflation issue 1
Break 1
Total Device Problems 11

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 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Clinical Innovations, LLC II Oct-15-2015
2 Clinical Innovations, LLC II Jan-27-2015

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