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 NumberS010 Date Received05/09/2022 Decision Date08/03/2022 Product Code LGW Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-05-09 |
| Decision Date | 2022-08-03 |
| PMA | P190002 |
| Supplement | S010 |
| Product Code | LGW |
| Advisory Committee | Neurology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SALUDA MEDICAL PTY LTD level 1, 407 Pacific Highway artarmon NSW 2 PMA NumberP190002 Supplement NumberS010 Date Received05/09/2022 Decision Date08/03/2022 Product Code LGW Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Modifications To Software And Firmware Intended To Reduce Programming Time In Patients With Significant Evoked Compound Action Potential (ECAP) Artifact Or Negative ECAP Values By Adding The ClearCAP Feature As Well As Minor Labeling Changes Which Include Providing Appropriate Instructions For The New ClearCAP Feature, Updating The Evoke Pocket Console (EPC) Product Name To “Evoke Patient Controller,” And Labelling Updates Required For Commercialization. |
| 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 |