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 | IMMULITE/IMMULITE 1000 PSA, IMMULITE 2000 PSA, IMMULITE/IMMULITE 1000 Third Generation PSA |
| Generic Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS INC.glyn Rhonwy, Llanberisgwynedd Ll55 4el LL554 PMA NumberP930027 Supplement NumberS026 Date Received02/28/2022 Decision Date03/29/2022 Product Code MTF Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-28 |
| Decision Date | 2022-03-29 |
| PMA | P930027 |
| Supplement | S026 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS INC. glyn Rhonwy, Llanberis gwynedd Ll55 4el LL554 PMA NumberP930027 Supplement NumberS026 Date Received02/28/2022 Decision Date03/29/2022 Product Code MTF Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement implementation Of A Change To The Physical State Of A Raw Material |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P930027 | Original Filing | |
| S028 | 2022-09-15 | 30-day Notice |
| S027 | ||
| S026 | 2022-02-28 | 30-day Notice |
| S025 | 2021-04-14 | 30-day Notice |
| S024 | 2020-08-12 | 30-day Notice |
| S023 | 2020-07-23 | 30-day Notice |
| S022 | 2019-11-25 | 30-day Notice |
| S021 | 2019-06-19 | Special (immediate Track) |
| S020 | 2018-09-28 | Real-time Process |
| S019 | 2018-03-19 | Special (immediate Track) |
| S018 | 2017-09-15 | Special (immediate Track) |
| S017 | 2016-08-17 | 135 Review Track For 30-day Notice |
| S016 | 2014-07-23 | 135 Review Track For 30-day Notice |
| S015 | 2012-05-30 | 135 Review Track For 30-day Notice |
| S014 | 2011-12-19 | 135 Review Track For 30-day Notice |
| S013 | 2011-08-16 | 30-day Notice |
| S012 | 2011-08-08 | 30-day Notice |
| S011 | 2011-02-18 | Real-time Process |
| S010 | 2009-11-02 | Normal 180 Day Track No User Fee |
| S009 | ||
| S008 | 2008-12-16 | Normal 180 Day Track |
| S007 | 2008-11-10 | Normal 180 Day Track No User Fee |
| S006 | 2003-11-28 | Real-time Process |
| S005 | 2003-01-21 | Real-time Process |
| S004 | 2001-01-02 | Panel Track |
| S003 | 1998-02-20 | Normal 180 Day Track |
| S002 | ||
| S001 | 1995-10-18 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00630414954196 | P930027 | 001 |
| 00630414982267 | P930027 | 003 |
| 00630414982229 | P930027 | 003 |
| 00630414982212 | P930027 | 003 |
| 00630414982205 | P930027 | 003 |
| 00630414982281 | P930027 | 004 |