PMA · Approved
Recalled · 2008Chorus RM Model 7034 DDDR Pacemaker Incl. Opus RM Model 4534 Ssir Pacemaker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
MicroPort CRM USA, Inc. · DXY Implantable Pacemaker Pulse-Generator
Approved on Mar 10, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 586-day review. It has been recalled once.
- Decided
- Mar 10, 1997
- Review
- 586 days
- Class
- Class III
- Product code
- DXY
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P950029 has 128 supplements since 1998: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1998 | 3 |
| 1999 | 4 |
| 2000 | 4 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 3 |
| 2005 | 3 |
| 2006 | 5 |
| 2007 | 2 |
| 2008 | 6 |
| 2009 | 9 |
| 2010 | 8 |
| 2011 | 7 |
| 2012 | 8 |
| 2013 | 12 |
| 2014 | 15 |
| 2015 | 6 |
| 2016 | 7 |
| 2017 | 3 |
| 2018 | 6 |
| 2019 | 1 |
| 2020 | 4 |
| 2021 | 3 |
| 2023 | 3 |
| 2025 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DXY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 23, 2008 | Not classified | Z-2235-2009 | Employee error | Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DXY devicesDXY Implantable Pacemaker Pulse-Generator: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXY
19in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXY
Too few DXY 510(k)s in any year since 2007 to give a median.
Recalls per year · DXY
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXY
810in 2025
MAUDE reports naming product code DXY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2,407 |
| 2008 | 0 | — | 0 | 2,649 |
| 2009 | 0 | — | 6 | 3,750 |
| 2010 | 0 | — | 1 | 4,187 |
| 2011 | 0 | — | 2 | 6,050 |
| 2012 | 0 | — | 0 | 3,709 |
| 2013 | 0 | — | 0 | 2,682 |
| 2014 | 0 | — | 0 | 5,604 |
| 2015 | 0 | — | 0 | 1,022 |
| 2016 | 15 | — | 0 | 542 |
| 2017 | 51 | — | 4 | 1,047 |
| 2018 | 45 | — | 0 | 2,070 |
| 2019 | 19 | — | 0 | 1,799 |
| 2020 | 23 | — | 0 | 546 |
| 2021 | 20 | — | 0 | 560 |
| 2022 | 14 | — | 0 | 784 |
| 2023 | 19 | — | 0 | 922 |
| 2024 | 20 | — | 0 | 773 |
| 2025 | 19 | — | 0 | 810 |
| 2026 | 19 | — | 0 | — |
https://510kreport.com/device/P950029 · printed Nov 6, 2026
Cite this page
510(k) Report. “P950029: Chorus RM Model 7034 DDDR Pacemaker Incl. Opus RM Model 4534 Ssir Pacemaker.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P950029
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026