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 transfer of bulk reagent manufacturing to another facility.
| Device | Aptima HBV Quant Assay |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Hologic, Inc |
| Date Received | 2018-05-11 |
| Decision Date | 2018-10-16 |
| PMA | P170025 |
| Supplement | S004 |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Supplement Type | 135 Review Track For 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170025 | Original Filing | |
| S018 | 2022-06-16 | 30-day Notice |
| S017 | 2021-12-14 | Real-time Process |
| S016 | 2020-07-09 | 30-day Notice |
| S015 | 2020-02-12 | 30-day Notice |
| S014 | 2019-12-23 | Real-time Process |
| S013 | 2019-06-21 | Normal 180 Day Track |
| S012 | 2019-04-19 | 30-day Notice |
| S011 | 2019-03-27 | 30-day Notice |
| S010 | 2019-03-18 | Real-time Process |
| S009 | 2019-02-21 | 30-day Notice |
| S008 | 2019-01-31 | 30-day Notice |
| S007 | 2018-12-31 | Real-time Process |
| S006 | 2018-11-29 | 30-day Notice |
| S005 | 2018-10-03 | 30-day Notice |
| S004 | 2018-05-11 | 135 Review Track For 30-day Notice |
| S003 | 2018-04-20 | 30-day Notice |
| S002 | 2018-03-12 | 30-day Notice |
| S001 | 2018-02-21 | Normal 180 Day Track |