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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, 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 NumberS068
Date Received04/07/2003
Decision Date05/09/2003
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to pisces z quad lead technical manuals and a change to the needle in the pisces z quad lead kits and in the model 3550-22 and model 3550-23 accessory kits from 15 gauge to the 14 gauge.
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