This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Atellica® IM Prostate-Specific Antigen (PSA) Assay |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP950021 Supplement NumberS025 Date Received03/22/2022 Decision Date03/29/2022 Product Code MTG Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-22 |
| Decision Date | 2022-03-29 |
| PMA | P950021 |
| Supplement | S025 |
| 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 PMA NumberP950021 Supplement NumberS025 Date Received03/22/2022 Decision Date03/29/2022 Product Code MTG Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Manufacture An Instrument Component At Another Location |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00630414203003 | P950021 | 001 |
| 00630414202990 | P950021 | 001 |
| 00630414202921 | P950021 | 002 |
| 00630414202938 | P950021 | 002 |
| 00630414598451 | P950021 | 002 |
| 00630414598444 | P950021 | 002 |
| 00630414202952 | P950021 | 002 |
| 00630414599823 | P950021 | 015 |
| 00630414599809 | P950021 | 015 |
| 00630414599816 | P950021 | 015 |
| 00630414294230 | P950021 | 015 |