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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.
 
DeviceLamitrode Tripole 16 Lead 60cm Length (Model 3219), TriCentrus 16 Lead 60cm Length (Model 3292), Octrode Lead 90cm Lengt
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP010032
Supplement NumberS193
Date Received09/29/2022
Decision Date05/05/2023
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of Magnetic Resonance (MR) Conditional labeling to the Tripole (Model 3219), TriCentrus (Model 3292), and Octrode (Model 3189) leads when used with the Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG), and an expansion of the MR scan conditions available for use with the Penta (Model 3228) lead.
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