Saluda Medical Evoke SCS System

FDA Premarket Approval P190002 S009

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

DeviceSaluda Medical Evoke SCS System
Generic NameStimulator, Spinal-cord, Totally Implanted For Pain Relief
ApplicantSALUDA MEDICAL PTY LTDlevel 1, 407 Pacific Highwayartarmon NSW 2 PMA NumberP190002 Supplement NumberS009 Date Received04/29/2022 Decision Date07/26/2022 Product Code LGW  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-04-29
Decision Date2022-07-26
PMAP190002
SupplementS009
Product CodeLGW 
Advisory CommitteeNeurology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressSALUDA MEDICAL PTY LTD
level 1, 407 Pacific Highway
artarmon NSW 2 PMA NumberP190002 Supplement NumberS009 Date Received04/29/2022 Decision Date07/26/2022 Product Code LGW  Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval For Updated Kit Configurations For The Percutaneous Lead Kit, Trial Lead Kit, And Spares Kit, Addition Of The New Active Anchor Kit, Updated Shelf-life From One To Two Years, And Minor Labeling Changes.

Supplemental Filings

Supplement NumberDateSupplement Type
P190002Original Filing
S011 2022-05-11 Real-time Process
S010 2022-05-09 Real-time Process
S009 2022-04-29 Real-time Process
S008 2022-04-27 30-day Notice
S007
S006 2022-04-12 30-day Notice
S005
S004 2022-03-21 30-day Notice
S003
S002 2022-03-07 Special (immediate Track)
S001

NIH GUDID Devices

Device IDPMASupp
09352307000643 P190002 000
09352307000049 P190002 000
09352307000063 P190002 000
09352307000087 P190002 000
09352307000100 P190002 000
09352307000131 P190002 000
09352307000155 P190002 000
09352307000179 P190002 000
09352307000193 P190002 000
09352307000230 P190002 000
09352307000292 P190002 000
09352307000339 P190002 000
09352307000346 P190002 000
09352307000360 P190002 000
09352307000384 P190002 000
09352307000407 P190002 000
09352307000414 P190002 000
09352307000025 P190002 000

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