| 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 | Prospera SCS System, Resilience Surgical Lead, Embrace One |
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| Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
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| Applicant | Biotronik Nro, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035 |
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| PMA Number | P210037 |
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| Supplement Number | S006 |
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| Date Received | 05/01/2024 |
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| Decision Date | 03/24/2025 |
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| Product Code |
LGW |
| Advisory Committee |
Neurology |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for changes made to update the Clinician Programmer Application (CP App), Patient Remote Application (PR App), and Neuro Service Center (NSC). Specifically, changes were made to update the Clinician Programmer Application to version 2.9.5 which includes changes such as bug removals, minor improvements, default value for stimulation mode has been changed to “Multiphase”, corrected ViStim formula to allow intended therapy programming range, changed lower limit for electrode failure from 200 Ohm to 100 Ohm, and reduction of Clinician Programmer Application startup time. Patient Remote Application to version 2.9.5 which includes changes such as bug removals, minor improvements, and reduced startup time for PR App. Neuro Service Center updated to 1.5.89 which includes changes such as bug fixes and minor improvements. |
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