PMA · Approved
ApprovedMaestro (R) II Model 534 Pacemaker System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiac Control Systems, Inc. · LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Approved on Jul 29, 1997 through premarket approval, which rests on the device’s own clinical evidence after a 47-day review.
- Decided
- Jul 29, 1997
- Review
- 47 days
- Class
- Class III
- Product code
- LWP
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
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 LWP? 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LWP devicesLWP Implantable Pulse Generator, Pacemaker (Non-Crt): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWP
46in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWP
Too few LWP 510(k)s in any year since 2007 to give a median.
Recalls per year · LWP
21in 2025
Class I (26 since 2007) Class II/III not classified
Adverse event reports per year · LWP
11,931in 2025
MAUDE reports naming product code LWP, 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 | 58 | — | 7 | 49 |
| 2008 | 87 | — | 2 | 496 |
| 2009 | 78 | — | 8 | 805 |
| 2010 | 66 | — | 7 | 678 |
| 2011 | 91 | — | 0 | 684 |
| 2012 | 123 | — | 0 | 1,087 |
| 2013 | 116 | — | 2 | 5,164 |
| 2014 | 126 | — | 2 | 9,400 |
| 2015 | 97 | — | 2 | 9,422 |
| 2016 | 97 | — | 1 | 12,354 |
| 2017 | 116 | — | 21 | 11,643 |
| 2018 | 97 | — | 0 | 14,936 |
| 2019 | 88 | — | 0 | 9,627 |
| 2020 | 90 | — | 0 | 8,989 |
| 2021 | 70 | — | 0 | 9,374 |
| 2022 | 65 | — | 0 | 14,286 |
| 2023 | 54 | — | 0 | 12,633 |
| 2024 | 58 | — | 4 (4) | 10,495 |
| 2025 | 46 | — | 21 (21) | 11,931 |
| 2026 | 40 | — | 1 (1) | — |
https://510kreport.com/device/P860027/S012 · printed Nov 6, 2026
Cite this page
510(k) Report. “P860027/S012: Maestro (R) II Model 534 Pacemaker System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P860027/S012
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026