FdaApprovalPulse / report
Berlin Heart, Inc.: PMA supplement approved for EXCOR Pediatric Ventricular Assist Device
Berlin Heart, Inc. (The Woodlands, Texas): PMA supplement approved for EXCOR Pediatric Ventricular Assist Device. Dated 64 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-03, 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 TX FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Berlin Heart, Inc. |
| Product | EXCOR Pediatric Ventricular Assist Device |
| Generic / ingredient | Ventricular (assist) bypass |
| Approval | PMA supplement (device change) |
| Application | P160035 S058 |
| Decided | 2026-09-01 |
| Panel / class | Cardiovascular |
| Sponsor location | The Woodlands, TX |
| Peer records CSV (18 TX 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: 2026-09-01
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FdaApprovalPulse records (TX first): Berlin Heart, Inc. · LivaNova USA, Inc. · Berlin Heart, Inc. · ABBOTT MEDICAL · ABBOTT MEDICAL · 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: Tue, 03 Nov 2026 05:14:00 GMT
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Peer benchmark and outreach value: Berlin Heart, Inc. and 18 Texas peers
- Texas FdaApprovalPulse records like this one: 18
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Texas peer: $3,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Berlin Heart, Inc. in The Woodlands, Texas?
The FDA approved EXCOR Pediatric Ventricular Assist Device (P160035 S058) for Berlin Heart, Inc. on 2026-09-01: PMA supplement (device change).
How does Berlin Heart, Inc. compare to other Texas FdaApprovalPulse records?
It is 64 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.
Berlin Heart, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Berlin Heart, Inc. | The Woodlands, TX | 2026-09-01 |
| 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.