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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 NumberH070003
Supplement NumberS015
Date Received04/03/2019
Decision Date11/12/2019
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 updates to the external pulse generator (epg) component of the neurx® diaphragm pacing system. These updates include the following:• primary battery options expanded from lithium metal batteries to include c-size alkaline battery. • primary battery lifetime extended by twenty percent under nominal stimulation settings. • ingress protection rating improvement (ipx4 to ip24). • programming connector accessibility improved to eliminate the need to remove primary battery for access. • twenty-two percent reduction in volumetric size. • prioritized audible alarms for error conditions. • unique alarm patterns for high, medium, and low priority error conditions. • alarm pattern repetition rate increased. • prioritized display messaging for error conditions.
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