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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 NameNeuRxDiaphragm Pacing System for Spinal Cord Injury
Classification Namediaphragmatic/phrenic nerve laparoscopically-implanted stimulator
Generic Namediaphragmatic/phrenic nerve laparoscopically-implanted stimulator
Applicant
SYNAPSE BIOMEDICAL
300 artino street
oberlin, OH 44074
HDE NumberH070003
Supplement NumberS013
Date Received02/11/2019
Decision Date03/13/2019
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 
Approval for a manufacturing process change involving the permaloc electrodes for the neurx dps. The change is being made to the permaloc electrodes initial cleaning step in which one of the current cleaning solvent (safezone ms-943) has been replaced by another solvent vertrel™ sdg.
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