# K163008: CareLink SmartSync Device Manager - Pacing System Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Feb 28, 2017 after 123 days
- Product code: DTA (Tester, Pacemaker Electrode Function)
- Device class: 2
- Regulation: 21 CFR 870.3720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P890003 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P890003: Synergyst  II Pulse Generator Models 7070 & 7071, Medtronic, Inc. (1989) Summary page 4.
- K910595: Model 5311B a-V Pacing System Analyzer, Medtronic Vascular (1991) Summary page 4.

## Indications for use
The base is intended to be used as part of the CareLink SmartSync device manager system. Clinicians use the base to analyze the electrical performance of cardiac leads during device implant or invasive troubleshooting. Clinicians use the base’s ECG connections along with the app display to view, measure, and record live cardiac waveforms. The base is intended to be used by healthcare professionals only in operating environments under direct medical supervision.

Source page: https://510kreport.com/device/K163008
Methodology: https://510kreport.com/methodology