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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 (DPS)
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 NumberS001
Date Received10/03/2011
Decision Date10/12/2011
Product Code
OIR[ Registered Establishments with OIR ]
Advisory Committee Anesthesiology
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 a change in the summary of safety and probable benefit. The updated summary of safety and probable benefit corrects under the heading "comment on peg placement at time of dps implant", the number of simultaneous peg and dps performed from 22 hud group patients to 24 hud group patients (27% of implanted patients to 28% of implanted patients) and occurrence of a problem with the peg placement at the same time as dps from 4. 5% to 4. 2%.
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