Senza Spinal Cord Stimulation (SCS) System

Stimulator, Spinal-cord, Totally Implanted For Pain Relief

FDA Premarket Approval P130022 S027

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.

Pre-market Approval Supplement Details

Approval for mechanical and design changes made to the current charger (cgr1000) for the senza spinal cord stimulation (scs) system to improve cosmetics and reduce the size of the charger. The modified patient remote charger will now be offered as model cgr2500.

DeviceSenza Spinal Cord Stimulation (SCS) System
Classification NameStimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic NameStimulator, Spinal-cord, Totally Implanted For Pain Relief
ApplicantNEVRO CORPORATION
Date Received2019-08-12
Decision Date2019-11-08
PMAP130022
SupplementS027
Product CodeLGW
Advisory CommitteeNeurology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address NEVRO CORPORATION 1800 Bridge Parkway redwood City, CA 94065

Supplemental Filings

Supplement NumberDateSupplement Type
P130022Original Filing
S027 2019-08-12 Real-time Process
S026 2019-07-29 Real-time Process
S025 2019-05-24 Real-time Process
S024
S023 2019-04-19 Real-time Process
S022
S021
S020
S019 2018-08-13 Normal 180 Day Track
S018 2018-07-23 Real-time Process
S017 2017-09-12 Normal 180 Day Track No User Fee
S016 2017-09-06 30-day Notice
S015 2017-07-14 30-day Notice
S014 2017-07-03 Normal 180 Day Track
S013 2017-05-16 Normal 180 Day Track
S012 2017-02-01 30-day Notice
S011 2016-12-19 30-day Notice
S010 2016-10-20 Normal 180 Day Track No User Fee
S009 2016-09-26 Real-time Process
S008 2016-05-02 Real-time Process
S007 2016-04-11 135 Review Track For 30-day Notice
S006 2016-03-16 30-day Notice
S005 2016-03-16 Real-time Process
S004 2015-11-23 Normal 180 Day Track
S003
S002 2015-09-04 Real-time Process
S001 2015-09-02 30-day Notice

NIH GUDID Devices

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