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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pessary, vaginal
Regulation Description Vaginal pessary.
Product CodeHHW
Regulation Number 884.3575
Device Class 2


Premarket Reviews
ManufacturerDecision
CONTIPI LTD.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
EASTMED INC.
  SUBSTANTIALLY EQUIVALENT 2
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
MARINA MEDICAL INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K031463  MARINA MEDICAL SILICONE PESSARY
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PROCTER & GAMBLE CO.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Reaction 1
Total Device Problems 1

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 1 0
Class III 0 0 0 0 0 0 1 1 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Cooper Surgical, Inc. III Mar-27-2013
2 CooperSurgical, Inc. III Nov-10-2015
3 CooperSurgical, Inc. II Mar-03-2015
4 CooperSurgical, Inc. III Nov-13-2014

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