Lungpacer Medical USA, Inc.: PMA supplement approved for AeroPace® System
Lungpacer Medical USA, Inc. (Exton, Pennsylvania): PMA supplement approved for AeroPace® System. Dated 136 days ago, it serves as a historical benchmark. Score 30/100. 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: 6 related PA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Lungpacer Medical USA, Inc. |
| Product | AeroPace® System |
| Generic / ingredient | Transvenous temporary phrenic nerve stimulator |
| Approval | PMA supplement (device change) |
| Application | P240012 S006 |
| Decided | 2026-06-22 |
| Panel / class | Anesthesiology |
| Sponsor location | Exton, PA |
| Peer records CSV (7 PA 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: 2026-06-22
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (PA first): Lungpacer Medical USA, Inc. · Centinel Spine, LLC · Zoll Manufacturing Corporation · Tiger Aesthetics Medical, LLC · Siemens Medical Solutions USA, Inc. · 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
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Peer benchmark and outreach value: Lungpacer Medical USA, Inc. and 7 Pennsylvania peers
- Pennsylvania FdaApprovalPulse records like this one: 7
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Pennsylvania peer: $1,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Lungpacer Medical USA, Inc. in Exton, Pennsylvania?
The FDA approved AeroPace® System (P240012 S006) for Lungpacer Medical USA, Inc. on 2026-06-22: PMA supplement (device change).
How does Lungpacer Medical USA, Inc. compare to other Pennsylvania FdaApprovalPulse records?
It is 136 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Lungpacer Medical USA, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Lungpacer Medical USA, Inc. | Exton, PA | 2026-06-22 |
| 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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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.