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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.
 
DeviceITREL3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS
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 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/material
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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