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 addition of the pt link pt200 for pre-treatment of tissue sections prior to staining with pd-l1 ihc 28-8 pharmdx.
| Device | PD-L1 IHC 28-8 PHARMDX (NON-SQUAMOUS NSCLC INDICATION) |
| Classification Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Generic Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Applicant | DAKO NORTH AMERICA, INC. |
| Date Received | 2016-07-07 |
| Decision Date | 2016-10-05 |
| PMA | P150025 |
| Supplement | S001 |
| Product Code | PLS |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150025 | Original Filing | |
| S015 | 2022-06-17 | 30-day Notice |
| S014 | 2021-07-12 | Normal 180 Day Track |
| S013 | 2019-12-16 | Panel Track |
| S012 | ||
| S011 | 2019-02-15 | 30-day Notice |
| S010 | 2018-12-21 | 30-day Notice |
| S009 | 2018-03-12 | 30-day Notice |
| S008 | 2017-12-26 | 30-day Notice |
| S007 | ||
| S006 | 2017-04-17 | 30-day Notice |
| S005 | 2016-12-29 | Normal 180 Day Track No User Fee |
| S004 | 2016-12-27 | Real-time Process |
| S003 | 2016-12-22 | Panel Track |
| S002 | 2016-08-19 | Real-time Process |
| S001 | 2016-07-07 | Real-time Process |