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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
Positioning Issue 3
Patient-device incompatibility 2
No Known Device Problem 2
Fracture 2
Improper or incorrect procedure or method 2
Device Issue 1
Failure to advance 1
Detachment of device component 1
Entrapment of device or device component 1
Kinked 1
Migration of device or device component 1
Difficult to remove 1
Incompatibility problem 1
Material integrity issue 1
Torn material 1
Device handling issue 1
Total Device Problems 22

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