PMA supplement
P910007 S031: AXSYM TOTAL PSA & ARCHITECT TOTAL PSA
FDA PMA supplement · Special (Immediate Track) · Abbott Laboratories
Key facts
| Original PMA | P910007 |
|---|---|
| Supplement number | S031 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | AXSYM TOTAL PSA & ARCHITECT TOTAL PSA |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | Abbott Laboratories |
| Product code | MTF |
| Received date | Sep 7, 2011 |
| Decision date | Sep 13, 2011 |
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: