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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.
 
DeviceEXTERNAL PULSE GENERATOR, 2 PORT HEADER, ADHESIVE POUCH, EPG; NON-ADHESIVE POUCH WITH BELT.
Generic Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS110
Date Received12/23/2015
Decision Date03/22/2016
Product Code LGW 
Advisory Committee Neurology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a material change to the approved pouch used with the External Pulse Generator, 16 Channel (Model 3599).
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