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U.S. Department of Health and Human Services

Product Classification
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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.
Physical State implanted electrodes, stimulator control, clinical programming station
Technical Method provides electrical stimulation for diaphragm movement
Target Area diaphragm
Review Panel Anesthesiology
Product CodeOIR
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Third Party Review Not Third Party Eligible
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