# P140009: Brio Neurostimulation System

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Jun 12, 2015 after 403 days
- Product code: MHY (Stimulator, Electrical, Implanted, For Parkinsonian Tremor)
- Device class: 3
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 6, 2025 · Class II · Z-0459-2026: There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPG
- Jun 2, 2017 · Class II · Z-2694-2017: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
- Jun 2, 2017 · Class II · Z-2696-2017: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
- Jun 2, 2017 · Class II · Z-2695-2017: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
- Jun 2, 2017 · Class II · Z-2693-2017: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

Source page: https://510kreport.com/device/P140009
Methodology: https://510kreport.com/methodology