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 |