PMA supplement
P820033 S010: PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR
FDA PMA supplement · 30-Day Notice · Asahi Kasei Medical Co., Ltd.
Key facts
| Original PMA | P820033 |
|---|---|
| Supplement number | S010 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| 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. |
| Product code | MDP |
| Received date | Feb 19, 2016 |
| Decision date | Mar 9, 2016 |
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: