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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 NameURO-STIM THERAPEUTIC STIMULATION UNIT
Classification Namestimulator, bladder
Generic Namestimulator, bladder
Applicant
William E. Kaplan, M.D.
2300 children's plaza, #24
chicago, IL 60614
HDE NumberH970003
Date Received09/12/1997
Decision Date12/16/1997
Product Code
NAZ
Docket Number 98M-0163
Advisory Committee Gastroenterology
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the urostim. This device is indicated for use in children for the treatment of neurogenic bladder disease secondary to spina bifida.
Approval OrderApproval Order
Supplements: S001 
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