PMA P190021S001

Device: ReActiv8 Implantable Neurostimulation System
Applicant: Mainstay Medical Limited
PMA number: P190021
Supplement: S001
Product code: QLK
Decision date: 2024-01-08
Classification: Neurology
Generic name: Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Approval order statement: Approval for labeling updates for the Mainstay ReActiv8 System which includes 1) MR conditional labeling 1.5T scans only; 2) inclusion of 2-year Clinical Data Follow Up and; 3) administrative changes to the Implant and Programming, and Patient Manual.

Current openFDA PMA Record#

Device: ReActiv8 Implantable Neurostimulation System
Applicant: Mainstay Medical Limited
PMA number: P190021
Supplement: S001
Product code: QLK
Generic name: Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Decision date: 2024-01-08
Decision code: APPR
Date received: 2022-07-14
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 which includes 1) MR conditional labeling 1.5T scans only; 2) inclusion of 2-year Clinical Data Follow Up and; 3) administrative changes to the Implant and Programming, and Patient Manual.