| 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 Date Received01/22/2019 Decision Date02/28/2022 Product Code LGW Advisory Committee Neurology Clinical TrialsNCT02924129 Expedited Review Granted? No |
| Date Received | 2019-01-22 |
| Decision Date | 2022-02-28 |
| PMA | P190002 |
| Supplement | S |
| Product Code | LGW |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SALUDA MEDICAL PTY LTD level 1, 407 Pacific Highway artarmon NSW 2 PMA NumberP190002 Date Received01/22/2019 Decision Date02/28/2022 Product Code LGW Advisory Committee Neurology Clinical TrialsNCT02924129 Expedited Review Granted? No Combination ProductNo Approval Order Statement Premarket Approval Application (PMA) For The Saluda Medical Evoke SCS System Approval OrderApproval Order SummarySummary Of Safety And Effectiveness LabelingLabeling Labeling Part 2 Supplements: |
| 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 |