TransMedics, Inc.: PMA supplement approved for Organ Care System (OCS) Lung System
TransMedics, Inc. (Andover, Massachusetts): PMA supplement approved for Organ Care System (OCS) Lung System. Dated 175 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: 36 related MA FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | TransMedics, Inc. |
| Product | Organ Care System (OCS) Lung System |
| Generic / ingredient | Normothermic machine perfusion system for the preservation of standard criteria donor lungs prior to transplantation |
| Approval | PMA supplement (device change) |
| Application | P160013 S021 |
| Decided | 2026-05-13 |
| Panel / class | Gastroenterology, Urology |
| Sponsor location | Andover, MA |
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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: 2026-05-13
- 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: TransMedics, Inc. and 37 Massachusetts peers
- Massachusetts FdaApprovalPulse records like this one: 37
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $7,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Score
What is the FdaApprovalPulse record for TransMedics, Inc. in Andover, Massachusetts?
The FDA approved Organ Care System (OCS) Lung System (P160013 S021) for TransMedics, Inc. on 2026-05-13: PMA supplement (device change).
How does TransMedics, Inc. compare to other Massachusetts FdaApprovalPulse records?
It is 175 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.
TransMedics, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| TransMedics, Inc. | Andover, MA | 2026-05-13 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Instylla, Inc. | Bedford, MA | 2026-10-21 |
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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.