Approval for a manufacturing site located at gen-probe incorporated, san diego, california for the manufacturing of the cervista hpv hr and the cervista hpv 16/18.
| Device | CERVISTA HPV HR TEST |
| Classification Name | Kit, Dna Detection, Human Papillomavirus |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | HOLOGIC, INC. |
| Date Received | 2013-08-02 |
| Decision Date | 2014-03-04 |
| PMA | P080014 |
| Supplement | S019 |
| Product Code | MAQ |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 250 Campus Drive marlborough, MA 01750 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P080014 | | Original Filing |
| S024 |
2018-10-16 |
30-day Notice |
| S023 |
2018-09-10 |
30-day Notice |
| S022 |
2018-08-31 |
30-day Notice |
| S021 |
2018-07-18 |
30-day Notice |
| S020 |
2013-11-08 |
30-day Notice |
| S019 |
2013-08-02 |
Normal 180 Day Track No User Fee |
| S018 |
2013-07-31 |
Normal 180 Day Track No User Fee |
| S017 |
2013-07-24 |
30-day Notice |
| S016 |
2012-12-20 |
Real-time Process |
| S015 |
2012-12-19 |
Real-time Process |
| S014 |
2012-11-13 |
30-day Notice |
| S013 |
2012-06-11 |
30-day Notice |
| S012 |
2012-04-17 |
Real-time Process |
| S011 |
2012-01-09 |
Real-time Process |
| S010 |
2011-12-28 |
30-day Notice |
| S009 |
2011-07-07 |
30-day Notice |
| S008 |
2011-06-02 |
30-day Notice |
| S007 |
2011-04-27 |
Normal 180 Day Track |
| S006 |
2010-12-30 |
30-day Notice |
| S005 |
2010-10-21 |
Real-time Process |
| S004 |
2010-10-05 |
30-day Notice |
| S003 |
2010-09-16 |
Real-time Process |
| S002 |
2010-06-03 |
30-day Notice |
| S001 |
2009-06-24 |
30-day Notice |
NIH GUDID Devices