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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device device, surgical, cryogenic
Regulation Description Cryogenic surgical device.
Product CodeGXH
Regulation Number 882.4250
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRICURE, INC.
  SUBSTANTIALLY EQUIVALENT 3
MYOSCIENCE INC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Adverse Event Without Identified Device or Use Problem 11
Tear, Rip or Hole in Device Packaging 5
Human-Device Interface Problem 1
User Interface 1
Scratched Material 1
No Apparent Adverse Event 1
Device Handling Problem 1
Total Device Problems 21

Recalls
Manufacturer Recall Class Date Posted
1 Myoscience Inc II Jul-22-2015

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