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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameNeuRx Diaphragm Pacing System for amyotrophic lateral sclerosis
Classification Namediaphragmatic/phrenic nerve laparoscopically-implanted stimulator
Generic Namediaphragmatic/phrenic nerve laparoscopically-implanted stimulator
Applicant
Synapse Biomedical
300 artino st.
oberline, OH 44074
HDE NumberH100006
Supplement NumberS010
Date Received03/18/2019
Decision Date11/22/2019
Product Code
OIR[ Registered Establishments with OIR ]
Advisory Committee Anesthesiology
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for design changes to the clinical station. The thermal printer used in the clinical station is replaced with a panel mounted printer. A new front panel switch and display interface assembly and an updated firmware is added to accommodate the new thermal printer.
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