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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device source, brachytherapy, radionuclide
Regulation Description Radionuclide brachytherapy source.
Product CodeKXK
Regulation Number 892.5730
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 3
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
AMERSHAM HEALTH
  SUBSTANTIALLY EQUIVALENT 1
BEST INDUSTRIES
  SUBSTANTIALLY EQUIVALENT 3
BIOCOMPATIBLES, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
IBT SA
  SUBSTANTIALLY EQUIVALENT 2
IMAGYN MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC
  SUBSTANTIALLY EQUIVALENT 1
MILLS BIOPHARMACEUTICALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PROXIMA
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL SPECIALTIES CORP.
  SUBSTANTIALLY EQUIVALENT 1
THERAGENICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
VARIAN
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Radiation exposure, unintended 3
Radiation overexposure 2
Deployment issue 1
Device operates differently than expected 1
No Known Device Problem 1
Not Applicable 1
Failure to deploy 1
Inadequate instructions for healthcare professional 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 1 1 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medi-Physics Inc. dba GE Healthcare II Nov-22-2011
2 Source Production & Equipment Inc II Jun-25-2015
3 Varian Medical Systems, Inc. II Apr-10-2012

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