ReActiv8 Implantable Neurostimulation System
FDA premarket approval P190021/S008 · decided 2024-12-12
Approval details
- PMA number
- P190021
- Supplement
- S008
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ReActiv8 Implantable Neurostimulation System
- Generic name
- Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
- Applicant
- Mainstay Medical Limited
- Date received
- 2024-11-14
- Decision date
- 2024-12-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- QLK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Swords, Co Dublin
- Statement
- approval for modifications to labeling related to two separate updates, clarification regarding the allowable receive coils compatible with the systems Magnetic Resonance (MR) conditional labelling and refinement of the considerations for patient selection
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