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.
Change of manufacturing location for a critical raw material.
| Device | Aptima HBV Quant Assay |
| Classification Name | Hepatitis Viral B Dna Detection |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Hologic, Inc |
| Date Received | 2018-11-29 |
| Decision Date | 2018-12-28 |
| PMA | P170025 |
| Supplement | S006 |
| Product Code | MKT |
| 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 |
| 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 |