Ventana Medical Systems, Inc.: PMA supplement approved for VENTANA HER2 Dual ISH DNA Probe Cocktail
Ventana Medical Systems, Inc. (Tucson, Arizona): PMA supplement approved for VENTANA HER2 Dual ISH DNA Probe Cocktail. Dated 71 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: 17 related AZ FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Ventana Medical Systems, Inc. |
| Product | VENTANA HER2 Dual ISH DNA Probe Cocktail |
| Generic / ingredient | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer |
| Approval | PMA supplement (device change) |
| Application | P190031 S016 |
| Decided | 2026-08-25 |
| Panel / class | Pathology |
| Sponsor location | Tucson, AZ |
| Peer records CSV (18 AZ records) | 🔒 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: 2026-08-25
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FdaApprovalPulse records (AZ first): Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Ventana Medical Systems · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · W. L. Gore & Associates, Inc. · Bard Peripheral Vascular, 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: Ventana Medical Systems, Inc. and 18 Arizona peers
- Arizona FdaApprovalPulse records like this one: 18
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Arizona peer: $3,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Ventana Medical Systems, Inc. in Tucson, Arizona?
The FDA approved VENTANA HER2 Dual ISH DNA Probe Cocktail (P190031 S016) for Ventana Medical Systems, Inc. on 2026-08-25: PMA supplement (device change).
How does Ventana Medical Systems, Inc. compare to other Arizona FdaApprovalPulse records?
It is 71 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.
Ventana Medical Systems, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Ventana Medical Systems, Inc. | Tucson, AZ | 2026-08-25 |
| 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.