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 SCS Neurostimulation System |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | Abbott Medical 6901 Prestion Road Plano, TX 75024 |
PMA Number | P140009 |
Supplement Number | S062 |
Date Received | 07/14/2020 |
Decision Date | 01/19/2021 |
Product Codes |
MHY NHL PJS |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for addition of BurstDR programs with multiple stimsets for Proclaim SCS System, programming enhancements for SCS therapy, cybersecurity enhancements and other minor enhancements for improvement. Approval for cybersecurity enhancements and other minor enhancements for improvement. |
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