PMA P190021S003

Device: Reactiv8 Implantable Neurostimulation System
Applicant: Mainstay Medical Limited
PMA number: P190021
Supplement: S003
Product code: QLK
Decision date: 2023-06-23
Classification: Neurology
Generic name: Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Approval order statement: Approval for a change in manufacturing layout for the ReActiv8® Implantable Neurostimulation System to introduce improvements in the distribution of the Surface Mount Technology (SMT) manufacturing area and expand capacity to meet increasing volume of business.

Current openFDA PMA Record#

Device: Reactiv8 Implantable Neurostimulation System
Applicant: Mainstay Medical Limited
PMA number: P190021
Supplement: S003
Product code: QLK
Generic name: Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
Decision date: 2023-06-23
Decision code: APPR
Date received: 2023-01-13
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in manufacturing layout for the ReActiv8® Implantable Neurostimulation System to introduce improvements in the distribution of the Surface Mount Technology (SMT) manufacturing area and expand capacity to meet increasing volume of business.