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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 family of neurostimulation leads

supplement #: S075
Medtronic Neuromodulation Oct 15, 2009 location change - manufacturer/sterilizer/packager/supplier  
interstim implantable neurostimulators

supplement #: S076
Medtronic Neuromodulation Jan 13, 2010 process change - manufacturer/sterilizer/packager/supplier  
interstim sacral nerve stimulation (sns) therapy

supplement #: S077
Medtronic Neuromodulation Mar 03, 2010 change design/components/specifications/material  
interstim implantable neurostimulators

supplement #: S078
Medtronic Neuromodulation Feb 12, 2010 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy system

supplement #: S079
Medtronic Neuromodulation Apr 13, 2010 change design/components/specifications/material  
interstim/interstim ii implantable neurostimulators

supplement #: S080
Medtronic Neuromodulation Feb 26, 2010 process change - manufacturer/sterilizer/packager/supplier  
interstim sacral nerve stimulation (sns) therapy for urinary control

supplement #: S081
Medtronic Neuromodulation Mar 03, 2010 process change - manufacturer/sterilizer/packager/supplier  
interstim therapy tined leads, models 3889 and 3093

supplement #: S082
Medtronic Neuromodulation Apr 02, 2010 postapproval study protocol - osb  
interstim family of implantable neurostimulators/leads/extension/test stimulation lead& kit

supplement #: S083
Medtronic Neuromodulation Apr 16, 2010 process change - manufacturer/sterilizer/packager/supplier  
interstim implantable neurostimulator

supplement #: S084
Medtronic Neuromodulation Apr 30, 2010 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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