PMA P190021S004

Device: Reactiv8 Implantable Neurostimulation System
Applicant: Mainstay Medical Limited
PMA number: P190021
Supplement: S004
Product code: QLK
Decision date: 2023-02-16
Classification: Neurology
Generic name: Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Approval order statement: Qualification of a commercially-available, equivalent programmer laptop for the ReActiv8 Implantable Neurostimulation System.

Current openFDA PMA Record#

Device: Reactiv8 Implantable Neurostimulation System
Applicant: Mainstay Medical Limited
PMA number: P190021
Supplement: S004
Product code: QLK
Generic name: Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Decision date: 2023-02-16
Decision code: OK30
Date received: 2023-01-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Qualification of a commercially-available, equivalent programmer laptop for the ReActiv8 Implantable Neurostimulation System.