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.
Change in auxiliary material/supplier used in the production of the probe mix to eliminate enzyme related stability problems.
| Device | TOP2A FISH PHARMDX |
| Generic Name | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion |
| Applicant | DAKO DENMARK A/S |
| Date Received | 2008-03-06 |
| Decision Date | 2008-03-26 |
| PMA | P050045 |
| Supplement | S002 |
| Product Code | NXG |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO DENMARK A/S 42 Produktionsvej 2600 Glostrup DK-26-2600 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P050045 | Original Filing | |
| S004 | 2011-12-23 | 135 Review Track For 30-day Notice |
| S003 | 2011-10-06 | 30-day Notice |
| S002 | 2008-03-06 | 30-day Notice |
| S001 | 2008-01-28 | Real-time Process |