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. |
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Device | Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor |
Generic Name | Dorsal root ganglion stimulator for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P150004 |
Supplement Number | S063 |
Date Received | 06/23/2023 |
Decision Date | 12/19/2023 |
Product Code |
PMP |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for expanded 1.5T MR conditional labeling to allow full-body scanning using integrated whole-body RF coils with any receive coil for the Proclaim DRG IPG (Model 3664) when implanted with the DRG 50cm leads (models MN10450-50, MN10450-50A) and associated implantable accessories including the port plug (Model 7108) and lead anchor. |
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