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.
Approval for changes in the manufacturing process of the monoclonal antibodies used in the production of the assays and change in the manufacturing facility used for the above manufacturing process from nisseiken co. , ltd. , tokyo, japan to tosoh aia, inc. In toyama, japan.
| Device | AIA-PACK PA PSA, ST AIA-PACK PA PSA |
| Classification Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Generic Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | TOSOH BIOSCIENCE, INC. |
| Date Received | 2005-06-06 |
| Decision Date | 2005-11-30 |
| PMA | P910065 |
| Supplement | S006 |
| Product Code | LTJ |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TOSOH BIOSCIENCE, INC. 6000 Shoreline Court suite 101 south San Francisco, CA 94080 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910065 | Original Filing | |
| S009 | 2019-05-20 | Special (immediate Track) |
| S008 | 2011-03-30 | Normal 180 Day Track |
| S007 | 2009-04-24 | Normal 180 Day Track |
| S006 | 2005-06-06 | Normal 180 Day Track |
| S005 | 2004-04-07 | Normal 180 Day Track |
| S004 | 2003-06-04 | Normal 180 Day Track |
| S003 | 2002-01-09 | Normal 180 Day Track |
| S002 | 1999-12-16 | Normal 180 Day Track |
| S001 | 1999-03-25 | Panel Track |