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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 SPINAL CORD STIMULATION (SCS) SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable programmable neurological electrical pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS049
Date Received11/16/2000
Decision Date12/13/2000
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
A manufacturing process change from a resistance weld to a laser weld.
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