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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 NumberS008
Date Received05/28/2003
Decision Date08/22/2003
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 USE OF THE MODEL A127 LEAD EXTENSION (MODELS 2341, 2342, 2343 AND 2346) WHICH IS 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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