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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceITREL(R) TOTALLY IMPLANTABLE SPINAL CORD STIM. SYS
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS001
Date Received01/18/1985
Decision Date02/07/1985
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
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