# P150035: Aveir VR Leadless System

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Mar 31, 2022 after 2,368 days
- Product code: PNJ (Leadless Pacemaker)
- Device class: 3
- Regulation: 21 CFR 870.3610
- Recalls of this device: 2 (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
- May 12, 2026 · Class II · Z-2405-2026: Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
- Feb 5, 2024 · Class II · Z-1695-2024: Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.

Source page: https://510kreport.com/device/P150035
Methodology: https://510kreport.com/methodology