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 | Aptima CMV Quant Assay |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | Hologic, Inc.10210 Genetic Center Drivesan Diego, CA 92121 PMA NumberP210029 Supplement NumberS001 Date Received06/16/2022 Decision Date07/20/2022 Product Code PAB Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-16 |
| Decision Date | 2022-07-20 |
| PMA | P210029 |
| Supplement | S001 |
| Product Code | PAB |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Hologic, Inc. 10210 Genetic Center Drive san Diego, CA 92121 PMA NumberP210029 Supplement NumberS001 Date Received06/16/2022 Decision Date07/20/2022 Product Code PAB Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Add Additional Monitoring And Final Release Criteria |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210029 | Original Filing | |
| S001 | 2022-06-16 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 15420045514584 | P210029 | 000 |
| 15420045514577 | P210029 | 000 |
| 15420045514560 | P210029 | 000 |
| 15420045514553 | P210029 | 000 |