Reactiv8 Implantable Neurostimulation System
FDA premarket approval P190021/S003 · decided 2023-06-23
Approval details
- PMA number
- P190021
- Supplement
- S003
- Supplement type
- 135 Review Track For 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
- 2023-01-13
- Decision date
- 2023-06-23
- Days to decision
- 161 days
- Decision code
- APPR
- Product code
- QLK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Swords, Co Dublin
- Statement
- Approval for a change in manufacturing layout for the ReActiv8® Implantable Neurostimulation System to introduce improvements in the distribution of the Surface Mount Technology (SMT) manufacturing area and expand capacity to meet increasing volume of business.
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