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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.
 
DeviceMEDTRONIC NEUROSTIMULATION SYSTEM (ITREL 3, RESTORE, SYNERGY, SYNERGY VERSITREL SYNERGY PLUS+, AND SYNERGY COMPACT PLUS+
Classification Namestimulator, spinal-cord, totally implanted for pain relief
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
MEDTRONIC NEUROMODULATION
7000 central avenue ne
minneapolis, MN 55432
PMA NumberP840001
Supplement NumberS091
Date Received01/20/2006
Decision Date02/08/2006
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR REVISED TEXT TO THE CAUTION IN THE "PLACING A PERCUTANEOUS LEAD" SECTION OF THE INSTRUCTIONS FOR USE SECTION OF THE FOLLOWING MANUALS: MODEL 3898 PISCES-OCTAD LEAD KIT IMPLANT MANUAL, MODEL 3487 A PISCES QUAD, MODEL 3887 PISCES QUAD COMPACT, AND MODEL 3888 PISCES QUAD PLUS LEAD KITS IMPLANT MANUAL, AND MODEL 3890 PISCES Z QUAD, MODEL 3891 PISCES Z QUAD COMPACT, AND MODEL 3892 PISCES Z QUAD PLUS LEAD KITS IMPLANT MANUAL.
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