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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 SPINAL CORD STIMULATION SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable programmable neurological electrical pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS062
Date Received05/20/2002
Decision Date07/25/2002
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model 3550-16 ez anchor accessory kit which will be labeled for use with the following medtronic, inc. Leads: pisces-quad model 3487a, resume model 3587a, temporary screening lead model 3861, pisces-quad compact model 3887, pisces-quad plus model 3888 and the pisces-octad model 3898. The model 3550-16 ez anchor is indicated as an aid in the management of chronic, intractable pain of the trunk or limbs.
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