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 an amorphous selenium digital receptor, a change in the name of the product to selenia and the addition of a soft copy display for interpretation of screening and diagnostic mammograms. The device, as modified, will be marketed under the trade name selenia full field digital mammography system and is indicated for generating digital mammographic images that can be used for screening and diagnosis of breast cancer. The selenia full field digital mammography system is intended for use in the same clinical applications as traditional screen-film mammographic systems. Mammographic images can be interpreted on either hard copy film or the selenia soft copy review workstation. Also, approval for the addition of the lorad facility, danbury, connecticut, as a manufacturing site for the selenia full field digital mammography system.
| Device | SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | HOLOGIC, INC. |
| Date Received | 2002-03-29 |
| Decision Date | 2002-10-02 |
| PMA | P010025 |
| Supplement | S001 |
| Product Code | MUE |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOLOGIC, INC. 36 Apple Ridge Road danbury, CT 06810 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010025 | Original Filing | |
| S020 | 2010-06-29 | Normal 180 Day Track |
| S019 | 2010-06-01 | Normal 180 Day Track |
| S018 | 2010-02-03 | 30-day Notice |
| S017 | 2009-11-05 | Real-time Process |
| S016 | 2009-04-13 | 30-day Notice |
| S015 | 2009-02-09 | Real-time Process |
| S014 | ||
| S013 | 2008-04-30 | Normal 180 Day Track |
| S012 | 2008-04-01 | Real-time Process |
| S011 | ||
| S010 | 2007-03-12 | Real-time Process |
| S009 | 2006-11-24 | Real-time Process |
| S008 | 2005-10-24 | Normal 180 Day Track |
| S007 | 2005-06-24 | Normal 180 Day Track |
| S006 | ||
| S005 | 2004-05-07 | Normal 180 Day Track |
| S004 | 2003-12-19 | Real-time Process |
| S003 | 2003-04-15 | Normal 180 Day Track |
| S002 | 2003-03-28 | Real-time Process |
| S001 | 2002-03-29 | Normal 180 Day Track |