Edwards Lifesciences, LLC: PMA supplement approved for Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent
Edwards Lifesciences, LLC (Irvine, California): PMA supplement approved for Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent. Dated 153 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: 109 related CA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Edwards Lifesciences, LLC |
| Product | Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent |
| Generic / ingredient | Pulmonary valve prosthesis percutaneously delivered |
| Approval | PMA supplement (device change) |
| Application | P200015 S076 |
| Decided | 2026-06-04 |
| Panel / class | Cardiovascular |
| Sponsor location | Irvine, CA |
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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: 2026-06-04
- Data refreshed: 2026-11-04
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Top FdaApprovalPulse records (CA first): Edwards Lifesciences, LLC · Edwards Lifesciences, LLC · Edwards Lifesciences, LLC · Edwards Lifesciences, LLC · 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: Wed, 04 Nov 2026 06:06:18 GMT
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Peer benchmark and outreach value: Edwards Lifesciences, LLC and 110 California peers
- California FdaApprovalPulse records like this one: 110
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $22,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for Edwards Lifesciences, LLC in Irvine, California?
The FDA approved Edwards SAPIEN 3 Transcatheter Pulmonary Valve (TPV) System with Alterra Adaptive Prestent (P200015 S076) for Edwards Lifesciences, LLC on 2026-06-04: PMA supplement (device change).
How does Edwards Lifesciences, LLC compare to other California FdaApprovalPulse records?
It is 153 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.
Edwards Lifesciences, LLC vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Edwards Lifesciences, LLC | Irvine, CA | 2026-06-04 |
| 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.