Lutonix: PMA supplement approved for Lutonix 035 Drug Coated Balloon Catheter
Lutonix (New Hope, Minnesota): PMA supplement approved for Lutonix 035 Drug Coated Balloon Catheter. Dated 118 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: 60 related MN FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Lutonix |
| Product | Lutonix 035 Drug Coated Balloon Catheter |
| Generic / ingredient | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Approval | PMA supplement (device change) |
| Application | P130024 S045 |
| Decided | 2026-07-09 |
| Panel / class | Cardiovascular |
| Sponsor location | New Hope, MN |
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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: 2026-07-09
- 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: Lutonix and 61 Minnesota peers
- Minnesota FdaApprovalPulse records like this one: 61
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Minnesota peer: $12,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Lutonix in New Hope, Minnesota?
The FDA approved Lutonix 035 Drug Coated Balloon Catheter (P130024 S045) for Lutonix on 2026-07-09: PMA supplement (device change).
How does Lutonix compare to other Minnesota FdaApprovalPulse records?
It is 118 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.
Lutonix vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Lutonix | New Hope, MN | 2026-07-09 |
| 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.