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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 urinary)

supplement #: S308
Medtronic Neuromodulation Mar 20, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S309
Medtronic Neuromodulation May 07, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system (sns urinary)

supplement #: S310
Medtronic Neuromodulation May 08, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S311
Medtronic Neuromodulation Jun 09, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S313
Medtronic Neuromodulation Sep 06, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S314
Medtronic Neuromodulation Sep 09, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system

supplement #: S315
Medtronic Neuromodulation Nov 03, 2020 change design/components/specifications/material  
interstim therapy system and verify evaluation system (sns urinary)

supplement #: S316
Medtronic Neuromodulation Oct 01, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim surescan mri leads

supplement #: S317
Medtronic Neuromodulation Nov 04, 2020 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system

supplement #: S318
Medtronic Neuromodulation Nov 12, 2020 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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