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.
| Device | PD-L1 IHC 22C3 pharmDx |
| Generic Name | Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1 |
| Applicant | Agilent Technologies, Inc.5301 Stevens Creek Blvdsanta Clara, CA 95051 PMA NumberP150013 Supplement NumberS025 Date Received08/08/2022 Decision Date11/03/2022 Product Code PLS Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-08-08 |
| Decision Date | 2022-11-03 |
| PMA | P150013 |
| Supplement | S025 |
| 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 | Agilent Technologies, Inc. 5301 Stevens Creek Blvd santa Clara, CA 95051 PMA NumberP150013 Supplement NumberS025 Date Received08/08/2022 Decision Date11/03/2022 Product Code PLS Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement The Cut Section Storage Recommendation For Cervical Cancer Tissue Will Be Updated, To Change The Recommended Maximum Duration Of Storage At 2-8ºC From 5 Months To 2 Months. |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150013 | Original Filing | |
| S025 | 2022-08-08 | Real-time Process |
| S024 | 2022-01-31 | Special (immediate Track) |
| S023 | 2021-11-17 | Special (immediate Track) |
| S022 | ||
| S021 | 2020-08-31 | Normal 180 Day Track |
| S020 | 2020-06-29 | Panel Track |
| S019 | 2020-02-06 | Normal 180 Day Track No User Fee |
| S018 | 2019-09-05 | Normal 180 Day Track No User Fee |
| S017 | 2019-06-14 | Normal 180 Day Track |
| S016 | 2019-02-25 | Panel Track |
| S015 | 2019-02-15 | 30-day Notice |
| S014 | ||
| S013 | 2018-12-21 | 30-day Notice |
| S012 | ||
| S011 | 2018-06-25 | Panel Track |
| S010 | 2018-03-12 | 30-day Notice |
| S009 | 2018-01-29 | Panel Track |
| S008 | 2017-12-26 | 30-day Notice |
| S007 | 2017-09-21 | Normal 180 Day Track No User Fee |
| S006 | 2017-04-19 | Panel Track |
| S005 | 2017-04-17 | 30-day Notice |
| S004 | 2016-12-27 | Real-time Process |
| S003 | 2016-08-19 | Real-time Process |
| S002 | 2016-06-28 | Real-time Process |
| S001 | 2015-12-31 | Panel Track |
| Device ID | PMA | Supp |
|---|---|---|
| 05700571107300 | P150013 | 000 |
| 05700573003563 | P150013 | 000 |
| 05700571112755 | P150013 | 000 |