Promega Corporation: PMA approval for OncoMate® MSI Dx Analysis System
Promega Corporation (Madison, Wisconsin): PMA approval for OncoMate® MSI Dx Analysis System. Dated 51 days ago, it serves as a historical benchmark. Score 55/100. 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: 4 related WI FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Promega Corporation |
| Product | OncoMate® MSI Dx Analysis System |
| Generic / ingredient | Nucleic Acid Based Assay, Microsatellite Instability |
| Approval | PMA original approval (new class III device) |
| Application | P250046 |
| Decided | 2026-09-15 |
| Panel / class | Medical Genetics |
| Sponsor location | Madison, WI |
| Peer records CSV (5 WI 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: 2026-09-15
- 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: Promega Corporation and 5 Wisconsin peers
- Wisconsin FdaApprovalPulse records like this one: 5
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Wisconsin peer: $1,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Score
- A new product launch.
What is the FdaApprovalPulse record for Promega Corporation in Madison, Wisconsin?
The FDA approved OncoMate® MSI Dx Analysis System (P250046) for Promega Corporation on 2026-09-15: PMA original approval (new class iii device).
How does Promega Corporation compare to other Wisconsin FdaApprovalPulse records?
It is 51 days old; check the official source for later updates before acting.
Promega Corporation vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Promega Corporation | Madison, WI | 2026-09-15 |
| Vivasure Medical , Ltd. | Galway | 2026-10-16 |
| Edwards Lifesciences, LLC | Irvine, CA | 2026-10-01 |
| Rejoni, Inc. | Bedford, MA | 2026-09-28 |
Related records
FdaApprovalPulse: PMA original approval (new class III device) FdaApprovalPulse: records in Wisconsin
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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.