The reactiv8 system is indicated for bilateral stimulation of the l2 medial branch of the dorsal ramus as it crosses the transverse process at l3 as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy and are not candidates for spine surgery.
| Device | ReActiv8 Implantable Neurostimulation System |
| Generic Name | Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief |
| Applicant | MAINSTAY MEDICAL LIMITED |
| Date Received | 2019-08-29 |
| Decision Date | 2020-06-16 |
| PMA | P190021 |
| Supplement | S |
| Product Code | QLK |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MAINSTAY MEDICAL LIMITED clonmel House Forster Way swords, Co Dublin K67F2 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P190021 | | Original Filing |
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NIH GUDID Devices