Axium Neurostimulator System
FDA premarket approval P150004/S023 · decided 2019-03-26
Approval details
- PMA number
- P150004
- Supplement
- S023
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Axium Neurostimulator System
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-05-30
- Decision date
- 2019-03-26
- Days to decision
- 300 days
- Decision code
- APPR
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for Axium Neurostimulator System. The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II*.
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