Reactiv8 Implantable Neurostimulation System
FDA premarket approval P190021/S004 · decided 2023-02-16
Approval details
- PMA number
- P190021
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process 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
- 2023-01-19
- Decision date
- 2023-02-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QLK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Swords, Co Dublin
- Statement
- Qualification of a commercially-available, equivalent programmer laptop for the ReActiv8 Implantable Neurostimulation System.
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