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 | |
| 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 |