Addition of an alternate qualified supplier for the critical component: 4 and 8 ml capacity glass vials.
| Device | VIDAS TOTAL PSA (TPSA) ASSAY |
| Generic Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Applicant | BioMerieux, Inc. |
| Date Received | 2014-02-03 |
| Decision Date | 2014-03-06 |
| PMA | P040008 |
| Supplement | S008 |
| Product Code | MTF |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | bioMerieux, Inc. 595 Anglum Rd. hazelwood, MO 63042 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040008 | | Original Filing |
| S013 |
2016-05-03 |
30-day Notice |
| S012 |
2015-07-06 |
30-day Notice |
| S011 |
2015-03-18 |
30-day Notice |
| S010 | | |
| S009 | | |
| S008 |
2014-02-03 |
30-day Notice |
| S007 |
2013-08-15 |
30-day Notice |
| S006 |
2013-02-12 |
30-day Notice |
| S005 |
2013-02-06 |
30-day Notice |
| S004 |
2012-12-18 |
30-day Notice |
| S003 |
2012-10-11 |
Real-time Process |
| S002 |
2012-01-09 |
30-day Notice |
| S001 |
2008-09-04 |
30-day Notice |
NIH GUDID Devices