Axium Neurostimulator System
FDA premarket approval P150004/S031 · decided 2019-07-29
Approval details
- PMA number
- P150004
- Supplement
- S031
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Axium Neurostimulator System
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2019-07-01
- Decision date
- 2019-07-29
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Move FMI manufacturing operations from its current site at Elk Grove Village, Illinois, USA to a facility in Lincolnshire, Illinois, USA. FMI is the currently approved supplier for molded silicone parts that go into the finished assembly and packaging of implantable pulse generators (IPGs), leads, lead extensions, lead adapters, and lead accessories.
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