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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 #: S298
Medtronic Neuromodulation Sep 27, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system

supplement #: S299
Medtronic Neuromodulation Nov 26, 2019 change design/components/specifications/material  
interstim therapy system, verify evaluation system

supplement #: S300
Medtronic Neuromodulation Oct 10, 2019 labeling change - indications/instructions/shelf life/tradename  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S301
Medtronic Neuromodulation Oct 13, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary programming systems)

supplement #: S302
Medtronic Neuromodulation Jul 30, 2020 change design/components/specifications/material  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S303
Medtronic Neuromodulation Dec 11, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S304
Medtronic Neuromodulation Dec 19, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S305
Medtronic Neuromodulation Jan 09, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S306
Medtronic Neuromodulation Jan 09, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S307
Medtronic Neuromodulation Feb 05, 2020 process change - manufacturer/sterilizer/packager/supplier  
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