ReActiv8 Implantable Neurostimulation System
FDA premarket approval P190021/S005 · decided 2023-08-24
Approval details
- PMA number
- P190021
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ReActiv8 Implantable Neurostimulation System
- Generic name
- Stimulator, neuromuscular, lower back muscles, totally implanted for pain relief
- Applicant
- Mainstay Medical Limited
- Date received
- 2023-04-06
- Decision date
- 2023-08-24
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- QLK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Swords, Co Dublin
- Statement
- Approval for a manufacturing site located at 2159 India Street, San Diego, California 92101, for the manufacturing of the ReActiv8 Implantable Neurostimulation System.
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