PMA
P820033: PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR
FDA PMA · Separator for therapeutic purposes, membrane automated blood cell/plasma · Asahi Kasei Medical Co., Ltd.
Key facts
| PMA number | P820033 |
|---|---|
| Trade name | PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR |
| Generic name | Separator for therapeutic purposes, membrane automated blood cell/plasma |
| Applicant | Asahi Kasei Medical Co., Ltd. |
| Owner/operator | Asahi Kasei Medical Co., Ltd. |
| Product code | MDP |
| Approval date | Jul 5, 1983 |
| Docket number | 83M-0236 |
| Notice date | Aug 12, 1983 |
| Establishment registration | 3009960884 |
| FEI number | 3009960884 |
At a glance
- 10–99 Supplements
- Apr 9, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: