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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 NameSNS URINARY INS INTERSTIM FAMILY
Classification Namestimulator, electrical, implantable, for incontinence
Generic Nameimplantable system for sacral nerve stimulation
Regulation Number876.5270
Applicant MEDTRONIC INC.
PMA NumberP970004
Supplement NumberS133
Date Received04/10/2012
Decision Date05/10/2012
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 Yes
Approval Order Statement 
Changes in the manufacturing process at medtronic?s supplier of grommets used in various medtronic neuromodulation implantable devices.
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