PMA · Approved

Approved

Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads

P960030PMAApproved Jan 29, 1998507-day reviewClass III

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Medical · NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

Approved on Jan 29, 1998 through premarket approval, which rests on the device’s own clinical evidence after a 507-day review. 2 later devices descend from it.

Decided: Jan 29, 1998
Review: 507 days
Class: Class III
Product code: NVN
Recalls: None

2 later devices descend from it, 1 citing it directly.

This deviceP960030 Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing…Abbott Medical · 1998
Descendant · cites it directly · 1 of its ownK090163 Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical · 2009
Descendant · 2 generations on · 0 of its ownK191469 Biotronik StyletsBiotronik, Inc. · 2019

Most influential descendants

Showing 2 of 2 · See all

K090163Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical · 2009 · cites it directly1descendant
K191469Biotronik StyletsBiotronik, Inc. · 2019 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	P960030	Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads	Abbott Medical	1998	—
+1	K090163	Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078	St Jude Medical	2009	—
+2	K191469	Biotronik Stylets	Biotronik, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2019	1	0

FIG. 1 — Lineage of P960030, 1998–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 NVN? 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

Get a 510(k) Report

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090163	Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078	St Jude Medical	2009	1

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.

What does this lineage say?

Of its descendants, K090163 (St Jude Medical, 2009) has gone furthest, with 1 descendant of its own.

How does its category compare?

All NVN devices

NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NVN

36in 2025

2007high 86 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NVN

Too few NVN 510(k)s in any year since 2007 to give a median.

Recalls per year · NVN

No recall names NVN since 2007.

Adverse event reports per year · NVN

23,350in 2025

2007high 24,991 (2023) · low 46 (2007)2025

MAUDE reports naming product code NVN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	46
2008	1	—	64
2009	10	—	85
2010	10	—	1,853
2011	11	—	6,196
2012	19	—	5,889
2013	7	—	7,653
2014	5	—	9,886
2015	10	—	10,137
2016	62	—	9,393
2017	67	—	11,613
2018	86	—	11,519
2019	56	—	16,873
2020	69	—	16,529
2021	60	—	17,757
2022	43	—	18,200
2023	38	—	24,991
2024	36	—	22,013
2025	36	—	23,350
2026	35	—	—

https://510kreport.com/device/P960030 · printed Nov 6, 2026

Cite this page

510(k) Report. “P960030: Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960030

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026