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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, indirect
Regulation Description Indirect pacemaker generator function analyzer.
Product CodeKRE
Regulation Number 870.3640
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 1
CYGNUS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Data Issue 5
Communication or transmission issue 2
No code available 1
Total Device Problems 8

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