FdaApprovalPulse / report
Berlin Heart, Inc.: PMA supplement approved for EXCOR Pediatric VAD
Berlin Heart, Inc. (The Woodlands, Texas): PMA supplement approved for EXCOR Pediatric VAD. Dated 21 days ago, it is in the active follow-up window. Score 60/100. 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 VAD |
| Generic / ingredient | Ventricular (assist) bypass |
| Approval | PMA supplement (device change) |
| Application | P160035 S056 |
| Decided | 2026-10-14 |
| 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: 2026-10-14
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FdaApprovalPulse records (TX first): LivaNova USA, Inc. · Berlin Heart, Inc. · ABBOTT MEDICAL · 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: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Texas 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 Berlin Heart, Inc. in The Woodlands, Texas?
The FDA approved EXCOR Pediatric VAD (P160035 S056) for Berlin Heart, Inc. on 2026-10-14: PMA supplement (device change).
How does Berlin Heart, Inc. compare to other Texas FdaApprovalPulse records?
It is 21 days old, still within a typical 45-day follow-up window.
Berlin Heart, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Berlin Heart, Inc. | The Woodlands, TX | 2026-10-14 |
| 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 |
Related records
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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.