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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameNEURX RA/4 DEVICE
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
Date Received03/30/2007
Decision Date06/17/2008
Product Code
OIR[ Registered Establishments with OIR ]
Docket Number 08M0378
Advisory Committee Anesthesiology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the neurx dpstm ra/4 diaphragm pacing stimulation system. This device is indicated for use in patients with stable, high spinal cord injuries with stimulatablediaphragms, but lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.
Approval OrderApproval Order
SummarySummary of Safety And Probable Benefit
LabelingLabeling
Supplements: S001 S002 S003 S005 S007 S009 S011 S012 S013 
S014 S015 S016 S017 
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