PMA supplement
P850048 S021: ACCESS HYBRITECH PSA WHO STANDARDIZATION
FDA PMA supplement · Panel Track · Beckman Coulter, Inc.
Key facts
| Original PMA | P850048 |
|---|---|
| Supplement number | S021 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ACCESS HYBRITECH PSA WHO STANDARDIZATION |
| Generic name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
| Applicant | Beckman Coulter, Inc. |
| Product code | MTF |
| Received date | Aug 21, 2007 |
| Decision date | May 9, 2008 |
| Docket number | 08M-0425 |
| Notice date | Jul 25, 2008 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: