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 | ActaStim-S Spine Fusion Stimulator |
| Generic Name | Stimulator, Bone Growth, Non-invasive |
| Applicant | Theragen, Inc.11220 Assett Loopsuite 101manassas, VA 20109 PMA NumberP190030 Supplement NumberS001 Date Received04/08/2022 Decision Date06/17/2022 Product Code LOF Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-04-08 |
| Decision Date | 2022-06-17 |
| PMA | P190030 |
| Supplement | S001 |
| Product Code | LOF |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Theragen, Inc. 11220 Assett Loop suite 101 manassas, VA 20109 PMA NumberP190030 Supplement NumberS001 Date Received04/08/2022 Decision Date06/17/2022 Product Code LOF Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For Modifications To The Device Battery Charger. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190030 | Original Filing | |
| S001 | 2022-04-08 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 00850372007264 | P190030 | 000 |
| 00850372007172 | P190030 | 000 |
| 00850372007189 | P190030 | 000 |
| 00850372007196 | P190030 | 000 |
| 00850372007202 | P190030 | 000 |
| 00850372007219 | P190030 | 000 |
| 00850372007226 | P190030 | 000 |
| 00850372007233 | P190030 | 000 |
| 00850372007240 | P190030 | 000 |
| 00850372007257 | P190030 | 000 |
| 00850372007165 | P190030 | 000 |