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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
medtronic interstim tined lead

supplement #: S030
Medtronic Neuromodulation Nov 24, 2004 postapproval study protocol  
interstim system

supplement #: S032
Medtronic Neuromodulation May 27, 2005 labeling change - indications/instructions/shelf life/tradename  
medtronic interstim sacral nerve stimulation (sns) system

supplement #: S033
Medtronic Neuromodulation Jun 30, 2006 change design/components/specifications/material  
interstim

supplement #: S034
Medtronic Neuromodulation Feb 21, 2006 process change - manufacturer/sterilizer/packager/supplier  
interstim-therapy for urinary control

supplement #: S035
Medtronic Neuromodulation Dec 23, 2005 change design/components/specifications/material  
interstim implantable neurostimulator

supplement #: S036
Medtronic Neuromodulation Nov 08, 2005 process change - manufacturer/sterilizer/packager/supplier  
medtronic interstim therapy for urinary control

supplement #: S037
Medtronic Neuromodulation Aug 31, 2006 labeling change - indications/instructions/shelf life/tradename  
interstim for urinary control

supplement #: S039
Medtronic Neuromodulation Jun 27, 2006 change design/components/specifications/material  
medtronic interstim tined lead models 3889 & 3093

supplement #: S040
Medtronic Neuromodulation Oct 23, 2007 postapproval study protocol  
interstim for urinary control

supplement #: S041
Medtronic Neuromodulation Nov 07, 2007 change design/components/specifications/material  
  We welcome your comments and feedback about Devices@FDA.
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