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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 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 NumberS011
Date Received12/05/2019
Decision Date01/03/2020
Product Code
OIR[ Registered Establishments with OIR ]
Advisory Committee Anesthesiology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Manufacturing change to gear component of the needle pivot assembly on the electrode delivery instrument.
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