PMA supplement
P820033 S016: Plasmaflo OP-05W(A)
FDA PMA supplement · 30-Day Notice · Asahi Kasei Medical Co., Ltd.
Key facts
| Original PMA | P820033 |
|---|---|
| Supplement number | S016 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Plasmaflo OP-05W(A) |
| Generic name | Separator for therapeutic purposes, membrane automated blood cell/plasma |
| Applicant | Asahi Kasei Medical Co., Ltd. |
| Product code | MDP |
| Received date | Dec 9, 2022 |
| Decision date | Jan 5, 2023 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: