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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(R) 3 AND SYNERGY(TM) SPINAL CORD STIMULATION SYSTEMS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable programmable neurological electrical pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS051
Date Received02/01/2001
Decision Date07/31/2001
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Aproval for the medtronic model 7495lz low impedance extension which will be used with the itrel(r) 3 and synergy(tm) spinal cord stimulation systems.
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