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U.S. Department of Health and Human Services

Product Classification

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Device implanted diaphragmatic/phrenic nerve stimulator
Regulation Description Implanted diaphragmatic/phrenic nerve stimulator.
Definition Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86
Regulation Medical Specialty Neurology
Review Panel Anesthesiology
Product CodeGZE
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices (DHT1C)
Submission Type PMA
Regulation Number 882.5830
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? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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