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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(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nametotally implanted spinal cord stimulator for pain
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS008
Date Received06/11/1986
Decision Date07/14/1986
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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