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 updated product labeling and associated data.
| Device | PD-L1 IHC 28-8 PHARMDX |
| 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 | 2016-08-29 |
| Decision Date | 2017-02-24 |
| PMA | P150027 |
| Supplement | S003 |
| Product Code | PLS |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150027 | Original Filing | |
| S004 | 2016-12-27 | Real-time Process |
| S003 | 2016-08-29 | Normal 180 Day Track No User Fee |
| S002 | 2016-08-19 | Real-time Process |
| S001 | 2016-07-07 | Real-time Process |