PMA supplement
P160052 S001: PartoSure Test
FDA PMA supplement · Normal 180 Day Track No User Fee · Qiagen, Inc.
Key facts
| Original PMA | P160052 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | PartoSure Test |
| Generic name | Placental alpha microglobulin-1 immunoassay |
| Applicant | Qiagen, Inc. |
| Product code | QBB |
| Received date | May 11, 2018 |
| Decision date | Oct 11, 2019 |
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: