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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

supplement #: S390
Medtronic Neuromodulation Dec 18, 2023 labeling change - indications/instructions/shelf life/tradename  
interstim® therapy system, verify® evaluation system

supplement #: S391
Medtronic Neuromodulation Nov 29, 2023 process change - manufacturer/sterilizer/packager/supplier  
interstim® therapy system, verify® evaluation system

supplement #: S392
Medtronic Neuromodulation Dec 12, 2023 process change - manufacturer/sterilizer/packager/supplier  
interstim® therapy system, verify® evaluation system

supplement #: S393
Medtronic Neuromodulation Nov 22, 2023 process change - manufacturer/sterilizer/packager/supplier  
interstim® therapy system, verify® evaluation system

supplement #: S394
Medtronic Neuromodulation Jan 11, 2024 process change - manufacturer/sterilizer/packager/supplier  
(ezw) interstim® therapy system, verify® evaluation system

supplement #: S395
Medtronic Neuromodulation Mar 27, 2024 change design/components/specifications/material  
sns urinary neurostimulator implantable interstim

supplement #: S396
Medtronic Neuromodulation Feb 22, 2024 process change - manufacturer/sterilizer/packager/supplier  
interstim™ therapy system, verify™ evaluation system

supplement #: S397
Medtronic Neuromodulation Jun 11, 2024 change design/components/specifications/material  
interstim therapy system, verify evaluation system

supplement #: S398
Medtronic Neuromodulation Apr 24, 2024 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system, verify evaluation system

supplement #: S399
Medtronic Neuromodulation May 10, 2024 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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