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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.
 
DeviceTRIPOLE, TRIPOLE 16C, TRIPOLE 16, LAMITRODE 4, LAMITRODE 44, LAMITRODE S-4, LAMITRODE S-8, LAMITRODE 88, LAMITRODE WINGE
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS101
Date Received09/15/2015
Decision Date10/15/2015
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
IMPLEMENTATION OF A CHANGE TO THE TUMBLING PROCESS OF ELECTRODES USED ON THE SCS LEADS, EXTENSIONS, AND ADAPTERS.
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