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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceSenza Spinal Cord Stimulation (SCS) System
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
Nevro Corporation
1800 bridge parkway
redwood city, CA 94065
PMA NumberP130022
Supplement NumberS036
Date Received08/19/2020
Decision Date03/06/2021
Product Code LGW 
Advisory Committee Neurology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the Senza Bluetooth Trial system which consists of the following components: Bluetooth Trial Stimulator (TSM), Bluetooth Patient Remote (PTR), and Updated Clinician Programmer Software (PS). Accessory kits that support the Senza Bluetooth Trial system consist of the Trial Stimulator Pouch kit, Extra battery kit and the Magnet kit.
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