Algovita Spinal Cord Stimulation System

Stimulator, Spinal-cord, Totally Implanted For Pain Relief

FDA Premarket Approval P130028 S026

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

The addition of alternative suppliers for the housing subcomponent and the spring/coil contact block subcomponent of the algovita® internal pulse generator (ipg)

DeviceAlgovita Spinal Cord Stimulation System
Classification NameStimulator, Spinal-cord, Totally Implanted For Pain Relief
Generic NameStimulator, Spinal-cord, Totally Implanted For Pain Relief
ApplicantNuvectra Corporation
Date Received2019-07-12
Decision Date2019-08-09
PMAP130028
SupplementS026
Product CodeLGW
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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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