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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device analyzer, pacemaker generator function
Regulation Description Pacemaker generator function analyzer.
Product CodeDTC
Regulation Number 870.3630
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
ELA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
PACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Application interface becomes non-functional or program exits abnormally 1
Failure to pace or properly pace 1
Failure to sense 1
Total Device Problems 3

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