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.
Alternate warehouse established within the current facility. The change is being made for the storage of finished devices after they have been qa released.
| Device | HER2 CISH PHARMDX KIT |
| Generic Name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/neu Gene, Breast Cancer |
| Applicant | DAKO DENMARK A/S |
| Date Received | 2015-08-13 |
| Decision Date | 2015-09-10 |
| PMA | P100024 |
| Supplement | S007 |
| Product Code | NYQ |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | DAKO DENMARK A/S 42 Produktionsvej dk-2600 glostrup DK-26-2600 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100024 | Original Filing | |
| S013 | 2017-03-13 | 30-day Notice |
| S012 | 2017-03-13 | 30-day Notice |
| S011 | 2016-12-27 | Real-time Process |
| S010 | 2016-07-01 | Real-time Process |
| S009 | 2016-03-16 | 30-day Notice |
| S008 | 2016-01-08 | 30-day Notice |
| S007 | 2015-08-13 | 30-day Notice |
| S006 | 2014-12-03 | 30-day Notice |
| S005 | 2013-08-01 | 30-day Notice |
| S004 | 2012-11-16 | Normal 180 Day Track |
| S003 | 2012-09-20 | Real-time Process |
| S002 | 2012-07-11 | 30-day Notice |
| S001 | 2011-12-07 | Real-time Process |