PMA supplement
P830063 S016: PRISMAFLEX TPE 2000 Set
FDA PMA supplement · Real-Time Process · Vantive US Healthcare, LLC
Key facts
| Original PMA | P830063 |
|---|---|
| Supplement number | S016 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | PRISMAFLEX TPE 2000 Set |
| Generic name | Separator for therapeutic purposes, membrane automated blood cell/plasma |
| Applicant | Vantive US Healthcare, LLC |
| Product code | MDP |
| Received date | Mar 5, 2020 |
| Decision date | May 23, 2020 |
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: