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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
Classification Namediaphragmatic/phrenic nerve laparoscopically-implanted stimulator
Generic Namediaphragmatic/phrenic nerve laparoscopically-implanted stimulator
Applicant
SYNAPSE BIOMEDICAL
300 artino street
oberlin, OH 44074
HDE NumberH100006
Supplement NumberS008
Date Received05/14/2018
Decision Date03/27/2019
Product Code
OIR[ Registered Establishments with OIR ]
Advisory Committee Anesthesiology
Clinical Trials NCT03034317
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for revisions to device labeling that was updated to include information on the post-approval study (pas) study of neurx dps for als (amyotrophic lateral sclerosis).
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