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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameITREL SPINAL CORD STIMULATION SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nametotally implanted spinal cord stimulator for pai
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS041
Date Received07/24/1997
Decision Date01/20/1998
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of an alternative packaging material, uncoated petg (polyethylene terephthalate, glycol modifed) for the manufacture of the inner and outer packaging trays. The device, as modified, will be marketed under the trade name itrel and is indicated for spinal cord stimulation.
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