Saluda Medical Evoke® SCS System

FDA Premarket Approval P190002 S004

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 NumberS004 Date Received03/21/2022 Decision Date04/20/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-03-21
Decision Date2022-04-20
PMAP190002
SupplementS004
Product CodeLGW 
Advisory CommitteeNeurology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressSALUDA MEDICAL PTY LTD
level 1, 407 Pacific Highway
artarmon NSW 2 PMA NumberP190002 Supplement NumberS004 Date Received03/21/2022 Decision Date04/20/2022 Product Code LGW  Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
for The Addition Of A New Component Manufacturer (Heraeus Medical Components LLC) For The Evoke SCS System Stylets (60/90 Cm Bent And Straight)

Supplemental Filings

Supplement NumberDateSupplement Type
P190002Original Filing
S015 2022-09-30 Real-time Process
S014
S013 2022-09-19 Real-time Process
S012
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
09352307000155 P190002 000
09352307000131 P190002 000
09352307000100 P190002 000
09352307000087 P190002 000
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09352307000407 P190002 000
09352307000384 P190002 000
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09352307000230 P190002 000
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09352307000773 P190002 009
09352307000780 P190002 009
09352307000803 P190002 009
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09352307000797 P190002 009
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09352307001671 P190002 014
09352307001695 P190002 014
09352307001701 P190002 014
09352307001718 P190002 014
09352307001817 P190002 023

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