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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 NameMEDTRONIC INTERSTIM SACRAL NERVE STIMULATION (SNS) SYSTEM
Classification Namestimulator, electrical, implantable, for incontinence
Generic Nameimplantable system for sacral nerve stimulation
Regulation Number876.5270
ApplicantMEDTRONIC VASCULAR
PMA NumberP970004
Supplement NumberS033
Date Received09/30/2005
Decision Date06/30/2006
Product Code
EZW[ Registered Establishments with EZW ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the interstim neurostimulator (model 3058 interstim ii), patient programmer (model 3037 icon), therapy application software, tined leads (models 3889/3093), system accessories (model 37092 external antenna, torque hex wrench, tunneling tool), and labeling architecture.
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