| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | ReActiv8 Implantable Neurostimulation System |
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| Generic Name | Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief |
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| Applicant | MAINSTAY MEDICAL LIMITED
CLONMEL HOUSE FORSTER WAY
SWORDS, CO DUBLIN K67F2 |
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| PMA Number | P190021 |
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| Date Received | 08/29/2019 |
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| Decision Date | 06/16/2020 |
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| Product Code |
QLK |
| Docket Number | 20M-1583 |
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| Notice Date | 06/22/2020 |
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| Advisory Committee |
Neurology |
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| Clinical Trials | NCT02577354
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for 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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
|
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| Supplements: |
S001 S003 S004 S005 S006 |
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