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 NumberS006 Date Received04/12/2022 Decision Date05/12/2022 Product Code LGW Advisory Committee Neurology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-12 |
| Decision Date | 2022-05-12 |
| PMA | P190002 |
| Supplement | S006 |
| 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 NumberS006 Date Received04/12/2022 Decision Date05/12/2022 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 change In The Sterilization Process At Steris Applied Sterilization Technologies (Steris AST) By Increased Load Density, Reduction Of Injection Pressure Of EO Gas (reduction In EO Concentration), And Updated Chamber Temperature Specification And Tolerances |
| 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 |