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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stimulator, intracerebral/subcortical, implanted
Regulation Description Implanted intracerebral/subcortical stimulator for pain relief.
Definition Call for PMAs to be filed by 3/1/89 per 53 FR 43621 on 12/1/88
Product CodeGYZ
Regulation Number 882.5840
Device Class 3

Device Problems
Device operates differently than expected 3
Device remains implanted 2
Improper or incorrect procedure or method 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Impedance issue 1
Explanted 1
High impedance 1
Migration of device or device component 1
Total Device Problems 12

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