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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
sns urinary interstim therapy system and verify evaluation system

supplement #: S288
Medtronic Neuromodulation May 23, 2019 process change - manufacturer/sterilizer/packager/supplier  
sns urinary: interstim therapy system and verify evaluation system

supplement #: S289
Medtronic Neuromodulation May 24, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S290
Medtronic Neuromodulation Jun 03, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S291
Medtronic Neuromodulation Jul 05, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S292
Medtronic Neuromodulation Feb 19, 2020 change design/components/specifications/material  
interstim therapy system and verify evaluation system (snm urinary)

supplement #: S293
Medtronic Neuromodulation Jul 25, 2019 labeling change - indications/instructions/shelf life/tradename  
interstim therapy system, verify evaluation system

supplement #: S294
Medtronic Neuromodulation Sep 11, 2019 labeling change - indications/instructions/shelf life/tradename  
interstim therapy system, verify evaluation system

supplement #: S295
Medtronic Neuromodulation Aug 14, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S296
Medtronic Neuromodulation Aug 22, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S297
Medtronic Neuromodulation Sep 17, 2019 process change - manufacturer/sterilizer/packager/supplier  
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