The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls. The TPLC database is refreshed as each of the individual data sources is updated.
You can search the TPLC database by device name or procode to receive a full report about a particular product line.
In its current form, the TPLC database provides data by procode, or generic category of device, and not by individual submission or brand name. In the future, FDA plans to further refine this database to provide information specific to individual products from the Clinical Trials Database.
Total Product Life Cycle (TPLC) Database
The list below contains two examples of how TPLC data might be presented in the future. Please note that these documents are only examples and do not contain current information.