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 the manufacturing process of pma oligomers in the device.
| Device | TOP2A FISH PHARMADX KIT |
| Generic Name | Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion |
| Applicant | DAKO DENMARK A/S |
| Date Received | 2011-12-23 |
| Decision Date | 2012-06-01 |
| PMA | P050045 |
| Supplement | S004 |
| Product Code | NXG |
| Advisory Committee | Pathology |
| Supplement Type | 135 Review Track For 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 |