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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.
 
DeviceSlimTip DRG Trial Lead Kit, 50cm/90cm, Slim Tip DRG Implant Lead Kit 50cm/90cm, DRG Lead Extension Kit
Generic NameDorsal root ganglion stimulator for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP150004
Supplement NumberS026
Date Received09/04/2018
Decision Date12/03/2018
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 minor design changes for the Doral Root Ganglion (DRG) Leads and Extensions: a) increasing proximal terminal electrode spacing tolerance from +0.010 to +0.012 on the DRG leads and extension; and b) increasing balseal spacing tolerance from +0.010 to +0.013 on the DRG extension header and center the nominal spacing dimensions to the center of the balseal.
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