Xvivo Perfusion, Inc.: PMA supplement approved for XPS with Steen Solution Perfusate
Xvivo Perfusion, Inc. (Englewood, Colorado): PMA supplement approved for XPS with Steen Solution Perfusate. Dated 49 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: 3 related CO FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Xvivo Perfusion, Inc. |
| Product | XPS with Steen Solution Perfusate |
| Generic / ingredient | Normothermic preservation system for transplantation of initially unacceptable donor lungs |
| Approval | PMA supplement (device change) |
| Application | P180014 S014 |
| Decided | 2026-09-16 |
| Panel / class | Gastroenterology, Urology |
| Sponsor location | Englewood, CO |
| Peer records CSV (4 CO 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: 2026-09-16
- 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: Xvivo Perfusion, Inc. and 4 Colorado peers
- Colorado FdaApprovalPulse records like this one: 4
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Colorado peer: $800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Xvivo Perfusion, Inc. in Englewood, Colorado?
The FDA approved XPS with Steen Solution Perfusate (P180014 S014) for Xvivo Perfusion, Inc. on 2026-09-16: PMA supplement (device change).
How does Xvivo Perfusion, Inc. compare to other Colorado FdaApprovalPulse records?
It is 49 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.
Xvivo Perfusion, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Xvivo Perfusion, Inc. | Englewood, CO | 2026-09-16 |
| 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.