LUNGPACER MEDICAL USA, INC.

FDA Device Registration & Listing · Exton, PA, US · Registration 3014139597

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014139597
FEI Number
3014139597
Entity Name
LUNGPACER MEDICAL USA, INC.
City/State/Country
Exton, PA, US
Establishment Address
260 Sierra Dr Ste 116, Exton, PA 19341, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Lungpacer Medical USA, Inc. (Owner Number: 10092127)
Owner / Operator Contact Address
260 Sierra Drive, Suite 116, Exton, PA 19341, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P240012

All Registered Proprietary Names

AeroPace System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SDL Transvenous Temporary Phrenic Nerve Stimulator Unknown Class 3 N/A 2024-12-06

Official Correspondent

Judy Ways

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lungpacer Medical USA, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014139597. Last updated year: 2026. Please use registration number 3014139597 when referencing this establishment in official correspondence.
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