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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 NameITREL3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Nameimplantable programmable neurological electrical pulse generator
ApplicantMEDTRONIC VASCULAR
PMA NumberP840001
Supplement NumberS064
Date Received06/24/2002
Decision Date09/26/2002
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 
Approval for the model 3890 pisces z quad lead, model 3891 pisces z quad compact lead, model 3892 pisces z quad plus lead and model 3550-22 and 3550-23 lead revision kits. The devices are indicated as an aid in the management of chronic, intractable pain of the trunk or limbs.
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