This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for use of the thinprep imaging system with the slides prepared by the thinprep 5000 slide processor.
| Device | THINPREP IMAGING SYSTEM |
| Classification Name | Reader, Cervical Cytology Slide, Automated |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | HOLOGIC, INC. |
| Date Received | 2014-11-14 |
| Decision Date | 2015-06-02 |
| PMA | P020002 |
| Supplement | S010 |
| Product Code | MNM |
| Advisory Committee | Pathology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 250 Campus Drive marlborough, MA 01752 |
| 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 |