Axium Neurostimulator System
FDA premarket approval P150004/S008 · decided 2017-09-29
Approval details
- PMA number
- P150004
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Axium Neurostimulator System
- Generic name
- Dorsal root ganglion stimulator for pain relief
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-04-03
- Decision date
- 2017-09-29
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Approval for the Axium Dorsal Root Ganglion (DRG) External Pulse Generator (EPG) Neurostimulator System.
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