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Device | Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Abbott Medical 6901 Preston Road Plano, TX 75024 |
PMA Number | P010032 |
Supplement Number | S189 |
Date Received | 07/15/2022 |
Decision Date | 01/24/2023 |
Product Codes |
LGW QRB |
Docket Number | 23M-0399 |
Notice Date | 02/15/2023 |
Advisory Committee |
Neurology |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for expanding the indications to include diabetic peripheral neuropathy (DPN) of the lower extremities for the tonic stimulation mode. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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