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 modification of the cen 17 reference pna probes and adjustment of the concentration of the top2a gene targeted dna probes in vial 3 probe mix.
| Device | TOP2A FISH PHARMDX KIT |
| Generic Name | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion |
| Applicant | DAKO DENMARK A/S |
| Date Received | 2008-01-28 |
| Decision Date | 2008-02-13 |
| PMA | P050045 |
| Supplement | S001 |
| Product Code | NXG |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |