|
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 | S024 |
Date Received | 05/15/2019 |
Decision Date | 12/18/2019 |
Product Code |
LGW |
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 a new optional accessory tool - Nevro passing elevator accessory tool (PEAT) for use with Nevros Senza Spinal Cord Stimulation (SCS) System. |