Algovita Spinal Cord Stimulation System

FDA Premarket Approval P130028 S031

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 use for the algovita clinician programmer application and nuvectra bridge communicator as per the letter dated may 5, 2020.

DeviceAlgovita Spinal Cord Stimulation System
Generic NameStimulator, Spinal-cord, Totally Implanted For Pain Relief
ApplicantNuvectra Corporation
Date Received2019-11-05
Decision Date2020-05-05
PMAP130028
SupplementS031
Product CodeLGW 
Advisory CommitteeNeurology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Nuvectra Corporation 10675 Naples Street Ne blaine, MN 55449

Supplemental Filings

Supplement NumberDateSupplement Type
P130028Original Filing
S031 2019-11-05 Normal 180 Day Track
S030 2019-09-27 30-day Notice
S029 2019-08-28 30-day Notice
S028
S027 2019-07-29 30-day Notice
S026 2019-07-12 30-day Notice
S025
S024 2019-06-05 30-day Notice
S023 2019-05-02 30-day Notice
S022 2018-06-22 Real-time Process
S021 2018-05-29 30-day Notice
S020 2018-02-20 Real-time Process
S019
S018 2017-06-12 Normal 180 Day Track
S017 2017-05-08 30-day Notice
S016 2017-03-02 30-day Notice
S015 2017-02-28 30-day Notice
S014 2017-02-17 Real-time Process
S013 2017-01-13 Special (immediate Track)
S012 2016-07-22 30-day Notice
S011 2016-07-13 30-day Notice
S010 2016-06-16 30-day Notice
S009 2016-05-27 Real-time Process
S008 2016-05-24 30-day Notice
S007 2016-04-29 30-day Notice
S006 2016-04-13 30-day Notice
S005 2016-03-14 Real-time Process
S004 2016-03-14 Real-time Process
S003 2016-02-18 30-day Notice
S002 2016-01-19 30-day Notice
S001 2015-11-27 30-day Notice

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