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U.S. Department of Health and Human Services

Product Classification
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Device implanted phrenic nerve stimulator for central sleep apnea
Definition The device is intended to stimulate the phrenic nerve to produce diaphragm movement during sleep.
Physical State The device may include an implantable pulse generator (IPG), respiratory sensing and stimulation leads. The device may also include external components such as a physician programmer.
Technical Method The device is an implanted nerve stimulator which provides electrical stimulation of the phrenic nerve in order to contract the diaphragm and stimulate the patient to take a breath.
Target Area Phrenic nerve
Review Panel Anesthesiology
Product CodePSR
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		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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