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 NumberS013 Date Received09/19/2022 Decision Date12/15/2022 Product Code LGW Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-09-19 |
| Decision Date | 2022-12-15 |
| PMA | P190002 |
| Supplement | S013 |
| 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 NumberS013 Date Received09/19/2022 Decision Date12/15/2022 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 Design Changes To The Set Screw And Set Screw Block Components Of The Lead Extension, Including An Increase In Set Screw Block Inner Diameter, Increase In Thread Size Of The Set Screw And Set Screw Block Hole, And Other Minor Changes In Geometry. |
| 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 |