Approval for an additional manufacturing site for the filter manufacturing process. The site is located at cytyc new hampshire, londonderry, new hampshire.
| Device | THINPREP 2000 SYSTEM |
| Classification Name | Processor, Cervical Cytology Slide, Automated |
| Generic Name | Processor, Cervical Cytology Slide, Automated |
| Applicant | HOLOGIC, INC. |
| Date Received | 2003-10-31 |
| Decision Date | 2004-02-09 |
| PMA | P950039 |
| Supplement | S011 |
| Product Code | MKQ |
| Advisory Committee | Pathology |
| 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 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