Add an alternate supplier to manufacture resin used in the production of dimension vista® chemibead and sensibead reagents.
| Device | Dimension Vista TPSA Flex reagent cartridge (K6452) |
| 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 | 2019-06-19 |
| Decision Date | 2019-06-26 |
| PMA | P020027 |
| Supplement | S036 |
| 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 500 Gbc Drive, P O Box 6101 m/s 514 newark, DE 19714-6101 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P020027 | | Original Filing |
| S039 |
2021-11-18 |
30-day Notice |
| S038 |
2020-09-14 |
30-day Notice |
| S037 | | |
| S036 |
2019-06-19 |
30-day Notice |
| S035 |
2019-05-13 |
30-day Notice |
| S034 |
2018-09-28 |
Real-time Process |
| S033 |
2018-06-18 |
30-day Notice |
| S032 |
2018-04-17 |
30-day Notice |
| S031 | | |
| S030 |
2017-11-20 |
30-day Notice |
| S029 |
2017-10-16 |
30-day Notice |
| S028 |
2017-09-25 |
Normal 180 Day Track No User Fee |
| S027 |
2017-06-20 |
30-day Notice |
| S026 |
2017-04-26 |
30-day Notice |
| S025 |
2017-02-17 |
30-day Notice |
| S024 |
2016-08-03 |
30-day Notice |
| S023 |
2015-12-07 |
Normal 180 Day Track |
| S022 |
2015-06-04 |
135 Review Track For 30-day Notice |
| S021 |
2014-08-27 |
30-day Notice |
| S020 |
2013-05-03 |
30-day Notice |
| S019 |
2012-10-31 |
30-day Notice |
| S018 |
2012-03-08 |
30-day Notice |
| S017 |
2012-02-01 |
Real-time Process |
| S016 |
2011-11-22 |
30-day Notice |
| S015 |
2011-06-30 |
Normal 180 Day Track |
| S014 |
2010-10-18 |
Real-time Process |
| S013 |
2010-08-19 |
Normal 180 Day Track |
| S012 |
2010-07-06 |
Real-time Process |
| S011 |
2010-03-25 |
30-day Notice |
| S010 |
2009-05-26 |
Normal 180 Day Track |
| S009 |
2008-12-02 |
Normal 180 Day Track |
| S008 |
2008-03-03 |
Special (immediate Track) |
| S007 |
2008-02-26 |
30-day Notice |
| S006 |
2007-08-14 |
Real-time Process |
| S005 |
2006-12-06 |
30-day Notice |
| S004 |
2005-06-29 |
30-day Notice |
| S003 |
2005-04-01 |
Special (immediate Track) |
| S002 |
2005-01-31 |
30-day Notice |
| S001 |
2003-09-29 |
Real-time Process |
NIH GUDID Devices