Approval for the addition of a multi-tube unit (mtu) sidecar, continuous fluids module, waste-to-drain module, and shuttle module to the panther and panther fusion instruments.
| Device | Aptima HBV Quant Assay |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Hologic, Inc |
| Date Received | 2019-06-21 |
| Decision Date | 2019-12-16 |
| PMA | P170025 |
| Supplement | S013 |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Hologic, Inc 10210 Genetic Center Drive san Diego, CA 92121 |
Supplemental Filings
| 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 |
NIH GUDID Devices