# K190574: Patient Assistant Model PA97000

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Sep 24, 2019 after 202 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K864889 (1987). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150117: Medtronic Patient Asistant, Medtronic, Inc. (2015). Our reading of the summary gave K150177, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Patient Assistant Model PA96000”.

## Indications for use
The Patient Assistant model PA97000 initiates the recording of cardiac event data in the device memory of a Medtronic insertable cardiac monitor. The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic.

Source page: https://510kreport.com/device/K190574
Methodology: https://510kreport.com/methodology