ReActiv8 Implantable Neurostimulation System
Mainstay Medical Limited · Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief · Neurology
Open FDA's page for this record- PMA number
- P190021
- Supplement number
- S012
- Applicant
- Mainstay Medical Limited
- Street 1
- Clonmel House Forster Way
- City
- Swords, Co Dublin
- Zip
- K67F2K3
- Generic name
- Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
- Trade name
- ReActiv8 Implantable Neurostimulation System
- Product code
- QLK
- Advisory committee
- NE
- Advisory committee description
- Neurology
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited review flag
- N
- Date received
- 2026-06-25
- Decision date
- 2026-10-19
- Decision code
- APPR
- Ao statement
approval for revised magnetic resonance (MR) compatibility labeling in the ReActiv8® System Magnetic Resonance Imaging (MRI) Guidelines manual to include lead fragments up to 2 cm in length.
- Harmonized identifiers (openFDA)
- Device name
- Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3021520203, 3010326622, 1035166
- FEI number
- 3021520203, 3010326622, 1035166