# K970347: MPC (Model 7000) External Temporary Pacemaker System

- Pathway: 510(k) (Traditional)
- Applicant: Paladin Medical, Inc.
- Decided: Aug 29, 1997 after 214 days
- Product code: DTE (Pulse-Generator, Pacemaker, External)
- Device class: 2
- Regulation: 21 CFR 870.3600
- 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 K821791 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K821791: External Pulse Generator - EV4542, American Pacemaker Corp. (1982) Summary page 1.

## Indications for use
The MPC Model 7000 External Temporary Pacemaker System is indicated for temporary (1-10 days typical) ventricular cardiac pacing in a controlled clinical environment.

Source page: https://510kreport.com/device/K970347
Methodology: https://510kreport.com/methodology