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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 Small/Big Curve Delivery Sheath Kit, 22cm; DRG Lead Accessories Kit; SlimTip DRG Trial Lead Kit, 50cm and 90cm; Slim
Generic NameDorsal root ganglion stimulator for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP150004
Supplement NumberS024
Date Received06/18/2018
Decision Date09/14/2018
Product Code PMP 
Advisory Committee Neurology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for alternative ink for the pad printed marker bands on the DRG delivery sheaths.
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