Lung Bioengineering, Inc.: PMA supplement approved for LungFX Device
Lung Bioengineering, Inc. (Silver Spring, Maryland): PMA supplement approved for LungFX Device. Dated 20 days ago, it is in the active follow-up window. Score 60/100. As of 2026-11-04, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 8 related MD FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Lung Bioengineering, Inc. |
| Product | LungFX Device |
| Generic / ingredient | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
| Approval | PMA supplement (device change) |
| Application | P240033 S002 |
| Decided | 2026-10-16 |
| Panel / class | Gastroenterology, Urology |
| Sponsor location | Silver Spring, MD |
| Peer records CSV (9 MD records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Lung Bioengineering, Inc.
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Free first: a 10-record sample of MD records
See the real columns before you buy. One confirmation email, nothing else unless you opt in.
Unlock Lung Bioengineering + all 9 MD records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-10-16
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (MD first): Lung Bioengineering, Inc. · Life Technologies Corporation · Becton, Dickinson and Company · Becton, Dickinson and Company · Terumo Medical Corporation · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 06:06:18 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: Lung Bioengineering, Inc. and 9 Maryland peers
- Maryland FdaApprovalPulse records like this one: 9
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Maryland peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
60 / 100 Score
- Decided in the last 30 days.
What is the FdaApprovalPulse record for Lung Bioengineering, Inc. in Silver Spring, Maryland?
The FDA approved LungFX Device (P240033 S002) for Lung Bioengineering, Inc. on 2026-10-16: PMA supplement (device change).
How does Lung Bioengineering, Inc. compare to other Maryland FdaApprovalPulse records?
It is 20 days old, still within a typical 45-day follow-up window.
Lung Bioengineering, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Lung Bioengineering, Inc. | Silver Spring, MD | 2026-10-16 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
Related records
FdaApprovalPulse: PMA supplement (device change) FdaApprovalPulse: records in Maryland
More Maryland public-record feeds
SEC 8-K Corporate Trigger Events in Maryland Federal Alcohol Permit Holder Directory in Maryland Largest U.S. Greenhouse Gas Emitters by Company, Sector & State (EPA GHGRP) in Maryland Newly CLIA-Certified Laboratories by State & Certificate in Maryland Nonprofit Revenue, Expenses & Assets from Form 990 in Maryland FMCSA Trucking Insurance Cancellations by Carrier, Insurer & Fleet Size in Maryland New SBA 7(a) & 504 Loan Approvals in Maryland Credit Union Quarterly Changes, Mergers & New Charters (NCUA Call Reports) in Maryland
How to monitor Lung Bioengineering, Inc. and peer pma supplement (device change) records
Get new FdaApprovalPulse records like Lung Bioengineering, Inc. by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get new approvals in your categories
FdaApprovalPulse emails new device and drug approvals matching your approval types.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.