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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 | S041 |
Date Received | 02/12/2021 |
Decision Date | 05/10/2021 |
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 for a new 0.016 curved stylet with 22 degree band angle to be marketed with the Senza Spinal Cord Stimulation (SCS) System. This stylet will replace 0.012 curved stylet with 30 degree angle which is being discontinued. |