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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.
 
DeviceDRG Lead Extension Kit
Generic NameDorsal root ganglion stimulator for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP150004
Supplement NumberS015
Date Received09/13/2017
Decision Date10/13/2017
Product Code PMP 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Changes to the dorsal root ganglion (DRG) lead extension manufacturing process at the St. Jude Medical (SJM) Plano, Texas facility. Specifically, it requested updates to the DRG lead extension socket assembly and header molding processes. These changes only apply to the DRG lead extension header component assembly and molding process.
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