PMA P190021

Device: ReActiv8 Implantable Neurostimulation System
Applicant: Mainstay Medical Limited
PMA number: P190021
Product code: QLK
Decision date: 2025-06-20
Generic name: Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Approval order statement: approval for labeling updates for the Mainstay ReActiv8 System including: 1) inclusion of 5-year follow-up clinical data in the “Clinical Summary” manual and 2) updates to risks in the “Implant and Programming” manual and the “User Manual”.

Current openFDA PMA Record#

Device: ReActiv8 Implantable Neurostimulation System
Applicant: Mainstay Medical Limited
PMA number: P190021
Supplement: S009
Product code: QLK
Generic name: Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Decision date: 2025-06-20
Decision code: APPR
Date received: 2025-03-25
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: approval for labeling updates for the Mainstay ReActiv8 System including: 1) inclusion of 5-year follow-up clinical data in the “Clinical Summary” manual and 2) updates to risks in the “Implant and Programming” manual and the “User Manual”.