Adding an additional manufacturing site for the instrument module.
| Device | Atellica IM Prostate-Specific Antigen (PSA) Assay |
| Classification Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2019-02-01 |
| Decision Date | 2019-03-08 |
| PMA | P950021 |
| Supplement | S017 |
| Product Code | MTG |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P950021 | | Original Filing |
| S025 |
2022-03-22 |
30-day Notice |
| S024 |
2021-04-01 |
30-day Notice |
| S023 |
2020-09-29 |
30-day Notice |
| S022 |
2020-07-31 |
30-day Notice |
| S021 |
2020-03-09 |
30-day Notice |
| S020 |
2020-02-21 |
30-day Notice |
| S019 | | |
| S018 |
2019-07-03 |
Special (immediate Track) |
| S017 |
2019-02-01 |
30-day Notice |
| S016 |
2018-07-27 |
Real-time Process |
| S015 |
2017-08-01 |
Normal 180 Day Track |
| S014 |
2015-05-07 |
Normal 180 Day Track |
| S013 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S012 |
2010-08-06 |
30-day Notice |
| S011 |
2009-04-10 |
Normal 180 Day Track No User Fee |
| S010 |
2009-02-06 |
30-day Notice |
| S009 |
2009-03-06 |
Real-time Process |
| S008 |
2006-05-17 |
Normal 180 Day Track No User Fee |
| S007 |
2005-07-22 |
Real-time Process |
| S006 |
2003-07-16 |
Real-time Process |
| S005 |
2001-09-20 |
Normal 180 Day Track |
| S004 |
2001-09-20 |
Normal 180 Day Track |
| S003 |
2000-09-28 |
Normal 180 Day Track |
| S002 |
2000-07-31 |
Panel Track |
| S001 |
1998-12-22 |
Panel Track |
NIH GUDID Devices