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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.
 
DeviceProclaim Elite IPG
Generic Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS140
Date Received12/18/2017
Decision Date01/10/2018
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  
Alternate supplier manufacturing location for the drilling process for the Bluetooth (BLE) antenna (this also included new equipment models). The BLE antenna is a component of the spinal cord stimulation (SCS) and deep brain stimulation (DBS) implantable pulse generator (IPGs) headers.
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