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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulmonary (pulmonic) valvuloplasty catheters/percutaneous valvuloplasty catheter
Regulation Description Percutaneous catheter.
Definition Catheter is used for Percutaneous Transluminal or balloon Valvuloplasty (PTV) of the pulmonary (pulmonic) valve. Used on patients with isolated pulmonary stenosis and also on patients with valvular pulmonary stenosis with other minor congenital heart disease that does not require surgical intervention.
Product CodeOMZ
Regulation Number 870.1250
Device Class 2


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

Device Problems
Break 1
Peeled 1
Material rupture 1
Unraveled material 1
Component missing 1
Dislodged or dislocated 1
No Known Device Problem 1
Total Device Problems 7

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