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.
Device | Saluda Medical Evoke® SCS System |
Generic Name | Stimulator, Spinal-cord, Totally Implanted For Pain Relief |
Applicant | SALUDA 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 Received | 2022-03-21 |
Decision Date | 2022-04-20 |
PMA | P190002 |
Supplement | S004 |
Product Code | LGW |
Advisory Committee | Neurology |
Supplement Type | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | SALUDA 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) |
Supplement Number | Date | Supplement Type |
---|---|---|
P190002 | Original 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 |