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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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435 supplements returned for P970004

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Device Name Company Date Approved Supplement Reason Other Information
verify evaluation system for interstim therapy for urinary control and bowel control

supplement #: S187
Medtronic Neuromodulation Jun 26, 2015 change design/components/specifications/material  
interstim therapy system

supplement #: S188
Medtronic Neuromodulation Feb 06, 2015 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system

supplement #: S189
Medtronic Neuromodulation Feb 10, 2015 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system

supplement #: S190
Medtronic Neuromodulation Mar 06, 2015 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system

supplement #: S192
Medtronic Neuromodulation Mar 26, 2015 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system

supplement #: S193
Medtronic Neuromodulation Mar 27, 2015 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system

supplement #: S194
Medtronic Neuromodulation Apr 03, 2015 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system

supplement #: S195
Medtronic Neuromodulation Apr 02, 2015 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system

supplement #: S196
Medtronic Neuromodulation Apr 17, 2015 process change - manufacturer/sterilizer/packager/supplier  
medtronic interstim sacral nerve stimulation therapy system

supplement #: S197
Medtronic Neuromodulation Oct 04, 2016 labeling change - pas  
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