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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 NameMEDTRONIC ITREL(R) & ITREL(R) SPINAL CORD STIM SYS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nametotally implanted spinal cord stimulator for pai
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS036
Date Received12/20/1994
Decision Date07/13/1995
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for relocation of the sterilization/packaging facility & a modification in the sterilization process for models:7491,7492,7493,7494,7495,7496 & associated leads,receivers, & accessories new facility:columbia heights,minnesota 55421.
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