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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 NameDUAL CHANNEL ITREL SYNERGY NEUROSTIMULATION SYSTEM
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable programmable neurological electrical pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS042
Date Received10/01/1998
Decision Date11/19/1999
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
Approval Order Statement 
Approval for the dual chamber intrel(r) synergy(tm) neurostimulation system as well as the model 7459 memorymod software for use with the existing itrel(r) 3 spinal cord stimulation system.
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