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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.
 
DeviceGENESIS NEUROSTIMULATION (IPG) SYSTEM
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
Abbott Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS005
Date Received10/24/2002
Decision Date12/23/2002
Product Code 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 QUICK LINK CONTROLLER MODEL 3860 FOR USE WITH THE GENESIS MODEL 3608, 3609, 3644 AND 3604 IMPLANTED PULSE GENERATORS WHICH ARE INDICATED AS AN AID IN THE MANAGEMENT OF CHRONIC INTRACTABLE PAIN OF THE TRUNK AND/OR LIMBS, INCLUDING UNILATERAL OR BILATERAL PAIN ASSOCIATED WITH FAILED BACK SURGERY SYNDROME, INTRACTABLE LOW BACK PAIN AND LEG PAIN.
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