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 dakolink software version 4. 1 update for the pd-l1 ihc 28-8 pharmdx (melanoma indication).
| Device | PD-L1 IHC 28-8 PHARMDX (Melanoma 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 | 2016-08-19 |
| Decision Date | 2016-12-01 |
| PMA | P150027 |
| Supplement | S002 |
| Product Code | PLS |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |