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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
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S319
Medtronic Neuromodulation Nov 12, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system, interstim micro implantable neurostimulator (sns urinary)

supplement #: S320
Medtronic Neuromodulation Nov 19, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S321
Medtronic Neuromodulation Nov 30, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary programming systems)

supplement #: S322
Medtronic Neuromodulation Feb 02, 2021 labeling change - indications/instructions/shelf life/tradename  
interstim surescan mri leads

supplement #: S323
Medtronic Neuromodulation Dec 16, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim surescan mri leads and percutaneous extensions

supplement #: S324
Medtronic Neuromodulation Dec 16, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system, and interstim micro implantable neurostimulator (sns urinary)

supplement #: S325
Medtronic Neuromodulation Dec 18, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system

supplement #: S326
Medtronic Neuromodulation Dec 16, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S327
Medtronic Neuromodulation Jan 08, 2021 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system

supplement #: S328
Medtronic Neuromodulation Apr 09, 2021 change design/components/specifications/material  
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