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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 Family of Implantable Pulse Generators
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 Preston Road
Plano, TX 75024
PMA NumberP010032
Supplement NumberS138
Date Received11/16/2017
Decision Date11/28/2017
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  
Supplier site move to a new supplier manufacturing location for ferrules used in the manufacture of battery lids within Implantable Pulse Generators (IPGs), in addition to a new Lid Assembly Machine (LAM) used to weld the ferrules to the battery lid.
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