# P950029: Chorus RM Model 7034 DDDR Pacemaker Incl. Opus RM Model 4534 Ssir Pacemaker

- Pathway: PMA
- Applicant: MicroPort CRM USA, Inc.
- Decided: Mar 10, 1997 after 586 days
- Product code: DXY (Implantable Pacemaker Pulse-Generator)
- Device class: 3
- Regulation: 21 CFR 870.3610
- Recalls of this device: 1 (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
- Sep 23, 2008 · Not classified · Z-2235-2009: Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew.

Source page: https://510kreport.com/device/P950029
Methodology: https://510kreport.com/methodology