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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 II SPINAL CORD STIMULATION SYSTE, INCLUDING A BIFURCATED Y-EXTENSION
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nametotally implanted spinal cord stimulator for pai
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS039
Date Received08/08/1995
Decision Date02/28/1997
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a y-extension (model 7498) and y-screening cable (model 3552).
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