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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSYNERGY 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 NumberS065
Date Received08/01/2002
Decision Date10/03/2002
Product Code
LGW[ Registered Establishments with LGW ]
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE MODEL 3898 PISCES-OCTAD LEAD AND THE MODEL 7471 OCTAPOLAR EXTENSION WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC, INTRACTABLE PAIN OF THE TRUNK OR LIMBS.
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