Biotronik, Inc.: PMA supplement approved for BIOexpress
Biotronik, Inc. (Lake Oswego, Oregon): PMA supplement approved for BIOexpress. Dated 19 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: 19 related OR FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Biotronik, Inc. |
| Product | BIOexpress |
| Generic / ingredient | implantable pacemaker Pulse-generator |
| Approval | PMA supplement (device change) |
| Application | P950037 S289 |
| Decided | 2026-10-16 |
| Panel / class | Cardiovascular |
| Sponsor location | Lake Oswego, OR |
| Peer records CSV (20 OR 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: 2026-10-16
- 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: Biotronik, Inc. and 20 Oregon peers
- Oregon FdaApprovalPulse records like this one: 20
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Oregon peer: $4,000 (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 Biotronik, Inc. in Lake Oswego, Oregon?
The FDA approved BIOexpress (P950037 S289) for Biotronik, Inc. on 2026-10-16: PMA supplement (device change).
How does Biotronik, Inc. compare to other Oregon FdaApprovalPulse records?
It is 19 days old, still within a typical 45-day follow-up window.
Biotronik, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Biotronik, Inc. | Lake Oswego, OR | 2026-10-16 |
| 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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FdaApprovalPulse: PMA supplement (device change) FdaApprovalPulse: records in Oregon
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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.