PMA
P850092: THERAPEUTIC APHERESIS SYSTEM
FDA PMA · Separator, automated, blood cell and plasma, therapeutic · Millipore Corp.
Key facts
| PMA number | P850092 |
|---|---|
| Trade name | THERAPEUTIC APHERESIS SYSTEM |
| Generic name | Separator, automated, blood cell and plasma, therapeutic |
| Applicant | Millipore Corp. |
| Owner/operator | MilliporeSigma |
| Product code | LKN |
| Approval date | Nov 18, 1986 |
| Docket number | 86M-0481 |
| Notice date | Dec 24, 1986 |
| Establishment registration | 3009432145 |
| FEI number | 3004422899 |
At a glance
- None Supplements
- Nov 18, 1986 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- Yes Withdrawn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: