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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.
 
Trade NameINTERSTIM SACRAL NERVE STIMULATION SYSTEM
Classification Namestimulator, electrical, implantable, for incontinence
Regulation Number876.5270
ApplicantMEDTRONIC VASCULAR
PMA NumberP970004
Supplement NumberS010
Date Received06/20/2000
Decision Date06/28/2000
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) inclusion of depth indicators along the body of the model 3057 test stimulation lead and associated labeling changes (3057 test stimulation components manual and 3065u manual), and 2) other minor labeling changes to these manuals for clarification of instructions and minor refinements to the lead testing specifications.
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