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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 NameNEUROCONTROL CORPORATION VOCARE BLADDER SYSTEM
Classification Namebladder system
Generic Namebladder system
Applicant
MDCI
49 plain st.
north attleboro, MA 02763
HDE NumberH980005
Date Received08/03/1998
Decision Date12/28/1998
Product Code
PAT
Docket Number 99M-0150
Advisory Committee Gastroenterology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the vocare(r) bladder system. This device is indicated for the treatment of patients who have clinically complete spinal cord lesions (asia classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 
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