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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 NumberH070003
Supplement NumberS007
Date Received03/16/2012
Decision Date05/25/2012
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 to update one aspect of the design of the electrode delivery instrument in h070003 to make it identical to the electrodedelivery instrument. It is indicated for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but lack control of their diaphragms. The deviceis 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.
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