Approval of the hologic thinprep® integrated imager. The device uses computer imaging technology to assist in primary cervical cancer screening of thinprep® pap test slides for the presence of atypical cells, cervical neoplasia, including its precursor lesions (low grade squamous intraepithelial lesions, high grade squamous intraepithelial lesions), and carcinoma as well as all other cytologic criteria as defined by the bethesda system: terminology for reporting results of cervical cytology.
| Device | ThinPrep Integrated Imager |
| Classification Name | Reader, Cervical Cytology Slide, Automated |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | HOLOGIC, INC. |
| Date Received | 2017-07-31 |
| Decision Date | 2018-04-18 |
| Notice Date | 2018-05-07 |
| PMA | P950039 |
| Supplement | S036 |
| Product Code | MNM |
| Docket Number | 18M-1580 |
| Advisory Committee | Pathology |
| Supplement Type | Panel Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 250 Campus Drive marlborough, MA 01752 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P950039 | | Original Filing |
| S040 |
2020-09-30 |
Normal 180 Day Track |
| S039 |
2020-04-15 |
135 Review Track For 30-day Notice |
| S038 |
2019-06-05 |
Real-time Process |
| S037 |
2018-11-23 |
30-day Notice |
| S036 |
2017-07-31 |
Panel Track |
| S035 |
2016-10-05 |
Special (immediate Track) |
| S034 |
2015-10-01 |
Real-time Process |
| S033 | | |
| S032 |
2014-11-21 |
30-day Notice |
| S031 |
2014-09-30 |
Real-time Process |
| S030 |
2014-08-29 |
Special (immediate Track) |
| S029 |
2014-08-15 |
30-day Notice |
| S028 |
2014-04-02 |
30-day Notice |
| S027 |
2013-12-31 |
30-day Notice |
| S026 |
2013-06-27 |
Normal 180 Day Track |
| S025 | | |
| S024 |
2012-02-14 |
Real-time Process |
| S023 | | |
| S022 | | |
| S021 |
2010-02-25 |
30-day Notice |
| S020 |
2009-10-01 |
30-day Notice |
| S019 | | |
| S018 |
2007-06-11 |
Normal 180 Day Track No User Fee |
| S017 |
2006-09-05 |
Special (immediate Track) |
| S016 |
2005-07-22 |
Normal 180 Day Track |
| S015 |
2005-04-01 |
Normal 180 Day Track |
| S014 |
2005-02-14 |
Normal 180 Day Track No User Fee |
| S013 |
2004-10-18 |
Normal 180 Day Track No User Fee |
| S012 |
2004-08-10 |
Normal 180 Day Track |
| S011 |
2003-10-31 |
Normal 180 Day Track No User Fee |
| S010 |
2003-02-19 |
Special (immediate Track) |
| S009 |
2003-01-21 |
Special (immediate Track) |
| S008 |
2001-12-10 |
Normal 180 Day Track |
| S007 |
2001-02-23 |
Normal 180 Day Track |
| S006 |
1999-10-27 |
Normal 180 Day Track |
| S005 |
1996-10-15 |
|
| S004 |
1996-10-02 |
Normal 180 Day Track |
| S003 |
1996-09-27 |
Normal 180 Day Track |
| S002 |
1996-07-30 |
Normal 180 Day Track |
| S001 |
1996-06-07 |
Normal 180 Day Track |
NIH GUDID Devices