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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 PMA to get an up-to-date view of this device.
Classification Namestimulator, electrical, implantable, for incontinence
Generic Nameimplantable system for sacral nerve stimulation
Regulation Number876.5270
PMA NumberP970004
Supplement NumberS076
Date Received12/14/2009
Decision Date01/13/2010
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Increasing the bake time for ceramic substrates prior to the solder prep reflow and adding an additional bake after the clean and dry processing step.