PMA P190021S005

Device: ReActiv8 Implantable Neurostimulation System
Applicant: Mainstay Medical Limited
PMA number: P190021
Supplement: S005
Product code: QLK
Decision date: 2023-08-24
Classification: Neurology
Generic name: Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Approval order statement: Approval for a manufacturing site located at 2159 India Street, San Diego, California 92101, for the manufacturing of the ReActiv8 Implantable Neurostimulation System.

Current openFDA PMA Record#

Device: ReActiv8 Implantable Neurostimulation System
Applicant: Mainstay Medical Limited
PMA number: P190021
Supplement: S005
Product code: QLK
Generic name: Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Decision date: 2023-08-24
Decision code: APPR
Date received: 2023-04-06
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at 2159 India Street, San Diego, California 92101, for the manufacturing of the ReActiv8 Implantable Neurostimulation System.