PMA supplement
P180051 S001: OCS Heart System
FDA PMA supplement · Panel Track · TransMedics, Inc.
Key facts
| Original PMA | P180051 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | OCS Heart System |
| Generic name | Organ care system (OCS) heart system |
| Applicant | TransMedics, Inc. |
| Product code | QIK |
| Received date | Nov 8, 2021 |
| Decision date | Apr 27, 2022 |
| Docket number | 22M-0715 |
| Notice date | May 3, 2022 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: