Axium Neurostimulator System
FDA premarket approval P150004/S010 · decided 2017-06-28
Approval details
- PMA number
- P150004
- Supplement
- S010
- 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
- 2017-06-02
- Decision date
- 2017-06-28
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Software update to the Automated Test Equipment (ATE) that will set the value of Open Threshold and Switch Threshold for all Proclaim, Infinity, and Proclaim DRG devices to a constant value of 253 during manufacturing instead of calculating the trim value using a formula.
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