Approval for additional claims to the current labeling. The additional claims consist of extension of the expiration date of the preservcyt sample vials to six weeks, reprocessing "unsatisfactory for evaluation" slides with a cytolyt solution and glacial acetic acid wash, and reference to the gen-probe aptima assays for the detection of chlamydia trachomatis and neisseria gonorrhoeae.
| Device | THINPREP 2000 SYSTEM |
| Classification Name | Processor, Cervical Cytology Slide, Automated |
| Generic Name | Processor, Cervical Cytology Slide, Automated |
| Applicant | HOLOGIC, INC. |
| Date Received | 2005-07-22 |
| Decision Date | 2006-01-18 |
| PMA | P950039 |
| Supplement | S016 |
| Product Code | MKQ |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 250 Campus Drive marlborough, MA 01752 |
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