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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, verify evaluation system (sns bowel neurostimulator)

supplement #: S278
Medtronic Neuromodulation Oct 09, 2018 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S279
Medtronic Neuromodulation Nov 13, 2018 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S280
Medtronic Neuromodulation Nov 30, 2018 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary neurostimulator implantable interstim)

supplement #: S281
Medtronic Neuromodulation Jan 08, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system

supplement #: S282
Medtronic Neuromodulation Mar 08, 2019 change design/components/specifications/material  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S283
Medtronic Neuromodulation Mar 22, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S284
Medtronic Neuromodulation Nov 06, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S285
Medtronic Neuromodulation Apr 02, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S286
Medtronic Neuromodulation May 01, 2019 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (urinary neurostimulator)

supplement #: S287
Medtronic Neuromodulation May 17, 2019 process change - manufacturer/sterilizer/packager/supplier  
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