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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device temporary cardiac support blood pump
Regulation Description Nonroller-type blood pump.
Definition Temporary circulatory support < 6 hours of use during off-pump bypass (OPCAB).
Product CodePBL
Regulation Number 870.4360
Device Class 3


Premarket Reviews
ManufacturerDecision
ABIOMED
  SE - WITH LIMITATIONS 1

Device Problems
Improper or incorrect procedure or method 2
Incompatibility problem 1
Fracture 1
Difficult to remove 1
No Known Device Problem 1
Detachment of device component 1
Device Issue 1
Entrapment of device or device component 1
Positioning Issue 1
Total Device Problems 10

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