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 addition of automatic exposure (aec) system, and related changes in operator's manual and qc test and qc manual under mqsa.
| Device | SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | HOLOGIC, INC. |
| Date Received | 2004-05-07 |
| Decision Date | 2005-02-18 |
| PMA | P010025 |
| Supplement | S005 |
| 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 |