Approval for the introduction of a new vial filler (the capmatic linear bambino filling system) at the gcd1 manufacturing facility.
| Device | PROGENSA PCA3 ASSAY |
| Classification Name | Prostrate Cancer Genes Nucleic Acid Amplification Test System |
| Generic Name | Prostrate Cancer Genes Nucleic Acid Amplification Test System |
| Applicant | GEN-PROBE INCORPORATED |
| Date Received | 2015-06-10 |
| Decision Date | 2015-11-12 |
| PMA | P100033 |
| Supplement | S004 |
| Product Code | OYM |
| Advisory Committee | Pathology |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GEN-PROBE INCORPORATED 10210 Genetic Center Drive san Diego, CA 92121 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P100033 | | Original Filing |
| S012 |
2020-07-09 |
30-day Notice |
| S011 |
2020-05-14 |
30-day Notice |
| S010 |
2019-02-21 |
30-day Notice |
| S009 |
2018-09-25 |
30-day Notice |
| S008 |
2018-02-08 |
30-day Notice |
| S007 |
2017-10-10 |
30-day Notice |
| S006 |
2015-09-02 |
30-day Notice |
| S005 |
2015-06-12 |
30-day Notice |
| S004 |
2015-06-10 |
135 Review Track For 30-day Notice |
| S003 |
2015-03-19 |
30-day Notice |
| S002 |
2014-12-22 |
30-day Notice |
| S001 |
2013-11-20 |
30-day Notice |
NIH GUDID Devices