- Device
- ReActiv8 Implantable Neurostimulation System
- Applicant
- Mainstay Medical Limited
- PMA number
- P190021
- Supplement
- S008
- Product code
- QLK
- Generic name
- Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
- Decision date
- 2024-12-12
- Decision code
- APPR
- Date received
- 2024-11-14
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for modifications to labeling related to two separate updates, clarification regarding the allowable receive coils compatible with the system’s Magnetic Resonance (MR) conditional labelling and refinement of the considerations for patient selection