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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 NumberS049
Date Received02/26/2008
Decision Date04/24/2008
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the technical manual for the test stimulation lead kit and test stimulation lead (model 3065u and model 3057, respectively) to explicitly describe the practice of implanting two temporary test stimulation leads during a single bilateral placement procedure for sequential testing within the seven day trial period.