Lung Bioengineering, Inc.: PMA supplement approved for LungFX Device
Lung Bioengineering, Inc. (Silver Spring, Maryland): PMA supplement approved for LungFX Device. Dated 19 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 S001 |
| 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 → |
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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
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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
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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 S001) 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 19 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 |
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FdaApprovalPulse: PMA supplement (device change) FdaApprovalPulse: records in Maryland
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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.