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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 SCS Neurostimulation System
Generic Namestimulator, spinal-cord, totally implanted for pain relief
ApplicantAbbott Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS176
Date Received06/01/2021
Decision Date11/17/2021
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
Approval Order Statement  
Approval for expanded magnetic resonance (MR) Conditional labeling for the Octrode 60cm Lead when implanted with the Proclaim XR IPGs (Models 3660 and 3662) and their associated accessories, including the port plug and lead anchors. This supplement requested expansion of the conditions of use within the MRI labeling to increase radiofrequency (RF) power limit from whole body SAR <=0.8 W/kg to normal operating mode (NOM) for scans using integrated body RF transmit coil with any receive coil, and also to expand implant locations eligible for MRI scans for lead tips in epidural space from T7 to T12 to C1 to S2.
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