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TPLC - Total Product Life Cycle
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Device brain stimulation programming planning software.
Regulation Description Brain stimulation programming planning software.
Definition The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.
Product CodeQQC
Regulation Number 882.5855
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NEUROMODULATION
  GRANTED 1
TURING MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

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