Chrysalis Intelligence · Sponsors · Lungpacer Medical USA, Inc.

Lungpacer Medical USA, Inc.

0 510(k) clearances · 9 PMAs

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Total clearances
0
None → None
Last 12 months
0
Product codes
0
Most recent
—
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
Class III

PMA approvals (9)

Total PMA records
9
Originals + supplements
Distinct product codes
1
First decision
2024-12-04
Most recent
2026-09-25
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-09-25 P240012-S008 AeroPace® System Real-Time Process SDL Transvenous Temporary Phrenic Nerve Stimulator Unknown
2026-06-22 P240012-S007 AeroPace® System Normal 180 Day Track No User Fee SDL Transvenous Temporary Phrenic Nerve Stimulator Unknown
2026-06-22 P240012-S006 AeroPace® System Real-Time Process SDL Transvenous Temporary Phrenic Nerve Stimulator Unknown
2026-02-20 P240012-S005 AeroPace® System Normal 180 Day Track No User Fee SDL Transvenous Temporary Phrenic Nerve Stimulator Unknown
2026-01-14 P240012-S004 AeroPace® System 30-Day Notice SDL Transvenous Temporary Phrenic Nerve Stimulator Unknown
2025-09-29 P240012-S003 AeroPace® System Real-Time Process SDL Transvenous Temporary Phrenic Nerve Stimulator Unknown
2025-09-23 P240012-S002 AeroPace® System Real-Time Process SDL Transvenous Temporary Phrenic Nerve Stimulator Unknown
2025-01-30 P240012-S001 AeroPace® System Normal 180 Day Track No User Fee SDL Transvenous Temporary Phrenic Nerve Stimulator Unknown
2024-12-04 P240012 AeroPace® System Original SDL Transvenous Temporary Phrenic Nerve Stimulator Unknown
Filings

510(k) clearances (none indexed)

Date K-number Device Code Class Specialty
Data source: openFDA · Generated 2026-10-06 10:35 · Last ingest 2026-10-06T14:35:17.195499 · Pipeline: Chrysalis Intelligence