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 | Senza Spinal Cord Stimulation (SCS) System |
Generic Name | Stimulator, spinal-cord, totally implanted for pain relief |
Applicant | Nevro Corporation 1800 Bridge Parkway Redwood City, CA 94065 |
PMA Number | P130022 |
Supplement Number | S023 |
Date Received | 04/19/2019 |
Decision Date | 07/18/2019 |
Product Code |
LGW |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to modify the patient remote cosmetically and to reduce the size; update the patient remote model numbers to PTR2300 and PTR2500; update the firmware for patient remote, model PTR2500 and the clinician programmer, model CLPG2000/CLPG2500 to support 5 stimulation therapy settings; and update the firmware to the IPG (renamed Omnia Senza IPG, Model NIPG2500) to support up to 5 stimulation settings. |
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