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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device diaphragmatic/phrenic nerve laparoscopically-implanted stimulator
Definition The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.
Product CodeOIR
Device Class Humanitarian Device Exemption

Device Problems
No pacing 1
Total Device Problems 1

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