Axium Neurostimulator System
FDA premarket approval P150004/S032 · decided 2019-11-19
Approval details
- PMA number
- P150004
- Supplement
- S032
- 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
- 2019-10-21
- Decision date
- 2019-11-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- PMP
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Plano, TX
- Statement
- Changes in the viable air sampling method and a corresponding change to the action and alert limits for the airborne microbes in the controlled access environments(CAE).
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