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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
Classification Namestimulator, electrical, implantable, for incontinence
Generic Nameimplantable system for sacral nerve stimulation
Regulation Number876.5270
ApplicantMEDTRONIC VASCULAR
PMA NumberP970004
Supplement NumberS034
Date Received10/06/2005
Decision Date02/21/2006
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the quality inspection process for the titanium can seam weld anaysis.
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