PMA
P850020: PROSORBA(TM) COLUMN
FDA PMA · Separator for therapeutic purposes, membrane automated blood cell/plasma · Fresenius Hemocare, Inc.
Key facts
| PMA number | P850020 |
|---|---|
| Trade name | PROSORBA(TM) COLUMN |
| Generic name | Separator for therapeutic purposes, membrane automated blood cell/plasma |
| Applicant | Fresenius Hemocare, Inc. |
| Owner/operator | Fresenius Medical Care Renal Therapies Group, LLC |
| Product code | MDP |
| Approval date | Dec 23, 1987 |
| Docket number | 88M-0019 |
| Notice date | Feb 23, 1988 |
| Establishment registration | 1225714 |
| FEI number | 1038965 |
At a glance
- 10–99 Supplements
- Oct 19, 2006 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- Yes Withdrawn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: