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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 CORPORATION VOCARE BLADDER SYSTEM
Classification Namestimulator, electrical, implantable, for incontinence
Generic Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
Applicant
Mdci
49 plain st.
north attleboro, MA 02763
HDE NumberH980005
Supplement NumberS002
Date Received11/17/2004
Decision Date10/31/2005
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
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