Reactiv8 Implantable Neurostimulation System
FDA premarket approval P190021/S006 · decided 2023-08-15
Approval details
- PMA number
- P190021
- Supplement
- S006
- 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
- 2023-07-13
- Decision date
- 2023-08-15
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- QLK
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Swords, Co Dublin
- Statement
- Removal of the spot weld process for Reactiv8 Implantable Neurostimulation Systems Implantable Pulse Generator (IPG) internal battery sleeve at Centro De Construccion De Cardioestimuladores Del Uruguay S.A.
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