ReActiv8 Implantable Neurostimulation System
FDA premarket approval P190021/S009 · decided 2025-06-20
Approval details
- PMA number
- P190021
- Supplement
- S009
- Supplement type
- Normal 180 Day 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
- 2025-03-25
- Decision date
- 2025-06-20
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- QLK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Swords, Co Dublin
- Statement
- approval for labeling updates for the Mainstay ReActiv8 System including: 1) inclusion of 5-year follow-up clinical data in the Clinical Summary manual and 2) updates to risks in the Implant and Programming manual and the User Manual.
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