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 Free PSA and IMMULITE® 2000 Free PSA |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITEDglyn Rhonwy. Llanberiscaernarfongwynedd, Ll55 4EL PMA NumberP060005 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code MTG Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-09-15 |
| Decision Date | 2022-10-14 |
| PMA | P060005 |
| Supplement | S016 |
| 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 MEDICAL SOLUTIONS DIAGNOSTICS LIMITED glyn Rhonwy. Llanberis caernarfon gwynedd, Ll55 4EL PMA NumberP060005 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 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 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 |
|---|---|---|
| P060005 | Original Filing | |
| S016 | 2022-09-15 | 30-day Notice |
| S015 | ||
| S014 | 2022-02-28 | 30-day Notice |
| S013 | 2021-04-14 | 30-day Notice |
| S012 | 2020-08-12 | 30-day Notice |
| S011 | 2020-07-23 | 30-day Notice |
| S010 | 2019-11-25 | 30-day Notice |
| S009 | 2018-09-28 | Real-time Process |
| S008 | 2012-05-30 | 135 Review Track For 30-day Notice |
| S007 | 2011-12-19 | 135 Review Track For 30-day Notice |
| S006 | 2011-08-16 | 30-day Notice |
| S005 | 2011-08-08 | 30-day Notice |
| S004 | 2011-02-18 | Real-time Process |
| S003 | 2009-11-02 | Normal 180 Day Track No User Fee |
| S002 | ||
| S001 | 2008-11-10 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 00630414977478 | P060005 | 001 |
| 00630414971575 | P060005 | 001 |