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 and 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 NumberS028 Date Received09/15/2022 Decision Date10/14/2022 Product Code MTF Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-15 |
| Decision Date | 2022-10-14 |
| PMA | P930027 |
| Supplement | S028 |
| 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 NumberS028 Date Received09/15/2022 Decision Date10/14/2022 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 Change In Material Composition Of The Glass Bulb Used In PMT (Photo Multiplier Tube) Assembly On The IMMULITE Family Of Instruments |
| 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 |