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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 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
Date Received10/12/2010
Decision Date09/28/2011
Product Code
OIR[ Registered Establishments with OIR ]
Docket Number 11-M0707
Advisory Committee Anesthesiology
Clinical Trials NCT00010374
NCT00420719
Expedited Review Granted? No
Combination ProductNo
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S005 
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