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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 NumberS012
Date Received08/24/2020
Decision Date11/07/2020
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 changes to the device design to make the electrode delivery tool component single-use and sterile.
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