Ventana Medical Systems, Inc. (Roche Tissue Diagnostics): PMA supplement approved for VENTANA MMR RxDx Panel
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) (Tucson, Arizona): PMA supplement approved for VENTANA MMR RxDx Panel. Dated 28 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: 17 related AZ FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) |
| Product | VENTANA MMR RxDx Panel |
| Generic / ingredient | Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay |
| Approval | PMA supplement (device change) |
| Application | P210001 S016 |
| Decided | 2026-10-08 |
| Panel / class | Pathology |
| Sponsor location | Tucson, AZ |
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| 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: 2026-10-08
- 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: Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) and 18 Arizona peers
- Arizona FdaApprovalPulse records like this one: 18
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Arizona peer: $3,600 (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 Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) in Tucson, Arizona?
The FDA approved VENTANA MMR RxDx Panel (P210001 S016) for Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) on 2026-10-08: PMA supplement (device change).
How does Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) compare to other Arizona FdaApprovalPulse records?
It is 28 days old, still within a typical 45-day follow-up window.
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-08 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
| Advanced Medical Solutions Limited | Plymouth | 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.