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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device neurosurgical laser with mr thermography
Definition Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.
Product CodeONO
Regulation Number 878.4810
Device Class 2


Premarket Reviews
ManufacturerDecision
CLINICAL LASERTHERMIA SYSTEMS AB
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Navigation, Inc. II Nov-17-2022
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