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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 NameNEUROCONTROL VOCARE BLADDER SYSTEM
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant
MDCI MEDICAL DEVICE CONSULTANTS, INC.
49 plain st.
north attleboro, MA 02276-4153
HDE NumberH980008
Supplement NumberS001
Date Received01/07/2000
Decision Date01/10/2000
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for replacing the current mri (magnetic resonance imaging) warning in the labeling with a precaution statement.
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