PMA
P810023: COBE CENTRY(R) TPE SYSTEM
FDA PMA · Separator, automated, blood cell and plasma, therapeutic · Gambro Bct, Inc.
Key facts
| PMA number | P810023 |
|---|---|
| Trade name | COBE CENTRY(R) TPE SYSTEM |
| Generic name | Separator, automated, blood cell and plasma, therapeutic |
| Applicant | Gambro Bct, Inc. |
| Owner/operator | Terumo BCT, INC. |
| Product code | LKN |
| Approval date | Mar 16, 1982 |
| Notice date | Apr 9, 1982 |
| Establishment registration | 1722028 |
| FEI number | 1000117351 |
At a glance
- 1–9 Supplements
- Jul 5, 1994 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: