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 the introduction of the thinprep® imager duo imaging station, hardware (camera and exterior housing) changes, and associated software changes.
| Device | THINPREP IMAGING SYSTEM |
| Classification Name | Reader, Cervical Cytology Slide, Automated |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | HOLOGIC, INC. |
| Date Received | 2014-01-30 |
| Decision Date | 2014-04-29 |
| PMA | P020002 |
| Supplement | S007 |
| Product Code | MNM |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |