ReActiv8 Implantable Neurostimulation System
FDA premarket approval P190021 · decided 2020-06-16
Approval details
- PMA number
- P190021
- Trade name
- 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
- Days to decision
- 292 days
- Decision code
- APPR
- Product code
- QLK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Swords, Co Dublin
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.