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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.
Classification Namediaphragmatic/phrenic nerve laparoscopically-implanted stimulator
Generic Namediaphragmatic/phrenic nerve laparoscopically-implanted stimulator
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
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the neurx dpstm diaphragm pacing system™. This device is indicated for use in amyotrophic lateral sclerosis (als) patients with a stimulatable diaphragm (both right and left portions) as demonstrated by voluntary contraction or phrenic nerve conduction studies, and who are experiencing chronic hypoventilation (ch), but not progressed to an fvc less than 45% predicted. For use only in patients 21 years of age or older.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S005