This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the thinprep imaging system. The device is indicated for assisting 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 cytological criteria as defined by the 2001 bethesda system: terminology for reporting results of cervical cytology.
| Device | THINPREP (R) IMAGING SYSTEM |
| Classification Name | Reader, Cervical Cytology Slide, Automated |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | HOLOGIC, INC. |
| Date Received | 2002-01-07 |
| Decision Date | 2003-06-06 |
| Notice Date | 2003-07-30 |
| PMA | P020002 |
| Supplement | S |
| Product Code | MNM |
| Docket Number | 03M-0339 |
| Advisory Committee | Pathology |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020002 | Original Filing | |
| S010 | 2014-11-14 | Normal 180 Day Track |
| S009 | 2014-10-16 | Real-time Process |
| S008 | 2014-06-20 | Real-time Process |
| S007 | 2014-01-30 | Real-time Process |
| S006 | 2011-11-29 | Real-time Process |
| S005 | 2010-08-19 | Special (immediate Track) |
| S004 | ||
| S003 | 2007-07-11 | Normal 180 Day Track No User Fee |
| S002 | 2006-03-30 | Real-time Process |
| S001 | 2005-05-03 | Normal 180 Day Track No User Fee |