PMA supplement
P910065 S007: ST AIA-PACK PA
FDA PMA supplement · Normal 180 Day Track · Tosoh Bioscience, Inc.
Key facts
| Original PMA | P910065 |
|---|---|
| Supplement number | S007 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ST AIA-PACK PA |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | Tosoh Bioscience, Inc. |
| Product code | MTF |
| Received date | Apr 24, 2009 |
| Decision date | Nov 30, 2009 |
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: