PMA
P180051: Organ Care System (OCS) Heart System
FDA PMA · Organ care system (OCS) heart system · TransMedics, Inc.
Key facts
| PMA number | P180051 |
|---|---|
| Trade name | Organ Care System (OCS) Heart System |
| Generic name | Organ care system (OCS) heart system |
| Applicant | TransMedics, Inc. |
| Owner/operator | TransMedics |
| Product code | QIK |
| Approval date | Sep 3, 2021 |
| Docket number | 21M-0989 |
| Notice date | Sep 10, 2021 |
| Establishment registration | 3003152463 |
| FEI number | 3003152463 |
At a glance
- 1–9 Supplements
- Dec 16, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: