ReActiv8 Implantable Neurostimulation System
FDA premarket approval P190021/S001 · decided 2024-01-08
Approval details
- PMA number
- P190021
- Supplement
- S001
- 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
- 2022-07-14
- Decision date
- 2024-01-08
- Days to decision
- 543 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 which includes 1) MR conditional labeling 1.5T scans only; 2) inclusion of 2-year Clinical Data Follow Up and; 3) administrative changes to the Implant and Programming, and Patient Manual.
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