ReActiv8 Implantable Neurostimulation System

FDA Premarket Approval P190021

Pre-market Approval Supplement Details

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.

DeviceReActiv8 Implantable Neurostimulation System
Generic NameStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
Date Received2019-08-29
Decision Date2020-06-16
Product CodeQLK 
Advisory CommitteeNeurology
Expedited ReviewNo
Combination Product No
Applicant Address MAINSTAY MEDICAL LIMITED clonmel House Forster Way swords, Co Dublin K67F2

Supplemental Filings

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Supplement NumberDateSupplement Type
P190021Original Filing

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