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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
master interstim therapy system, verify evaluation system

supplement #: S349
Medtronic Neuromodulation Dec 08, 2021 labeling change - indications/instructions/shelf life/tradename  
master interstim® therapy system

supplement #: S351
Medtronic Neuromodulation Jan 13, 2022 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S352
Medtronic Neuromodulation Mar 18, 2022 process change - manufacturer/sterilizer/packager/supplier  
interstim® therapy system, verify® evaluation system

supplement #: S353
Medtronic Neuromodulation Mar 14, 2023 change design/components/specifications/material  
interstim® therapy system, verify® evaluation system

supplement #: S354
Medtronic Neuromodulation Feb 26, 2022 process change - manufacturer/sterilizer/packager/supplier  
interstim® therapy system, verify® evaluation system

supplement #: S355
Medtronic Neuromodulation Feb 25, 2022 process change - manufacturer/sterilizer/packager/supplier  
interstim® therapy system, verify® evaluation system (sns urinary)

supplement #: S356
Medtronic Neuromodulation May 12, 2022 process change - manufacturer/sterilizer/packager/supplier  
interstim® therapy system, verify® evaluation system

supplement #: S357
Medtronic Neuromodulation Mar 30, 2022 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system

supplement #: S358
Medtronic Neuromodulation Mar 17, 2022 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system (sns urinary neurostimulator implantable interstim)

supplement #: S359
Medtronic Neuromodulation Apr 15, 2022 process change - manufacturer/sterilizer/packager/supplier  
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