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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 NumberS206
Date Received10/13/2015
Decision Date11/10/2015
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 
The update of manufacturing process changes in the surface treatment of metal piece part for the impacted implantable products (i. E. , titanium, platinum/iridium alloy, and stainless steel subcomponents) as well as minor updates to the surface treatment specifications for these subcomponents.