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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device balloon aortic valvuloplasty
Definition A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve.
Product CodeOZT
Regulation Number 870.1255
Device Class 2


Premarket Reviews
ManufacturerDecision
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 5
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
NUMED, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Retraction problem 20
Material rupture 5
Deflation issue 3
No Known Device Problem 3
Break 1
Leak 1
Difficult to remove 1
Detachment of device or device component 1
Total Device Problems 35

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

Recalls
Manufacturer Recall Class Date Posted
1 InterValve Inc II May-15-2014
2 Loma Vista Medical II Jun-21-2013

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