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 NumberS008 Date Received04/27/2022 Decision Date05/26/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-04-27 |
Decision Date | 2022-05-26 |
PMA | P190002 |
Supplement | S008 |
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 NumberS008 Date Received04/27/2022 Decision Date05/26/2022 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 to Add An Alternate Manufacturer For The Anchors Used In The Evoke Spinal Cord Stimulation System |
Supplement Number | Date | Supplement Type |
---|---|---|
P190002 | Original Filing | |
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 |
Device ID | PMA | Supp |
---|---|---|
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 |