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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceReActiv8 Implantable Neurostimulation System
Generic Namestimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Applicant
MAINSTAY MEDICAL LIMITED
clonmel house forster way
swords, co dublin K67F2
PMA NumberP190021
Date Received08/29/2019
Decision Date06/16/2020
Product Code QLK 
Docket Number 20M-1583
Notice Date 06/22/2020
Advisory Committee Neurology
Clinical Trials NCT02577354
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements:  
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