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 to modify the current approved labeling to include data and information from a direct-to-vial clinical study for high grade squamous intraepithelial and more severe lesions.
| Device | PREPSTAIN (TM) SYSTEM |
| Generic Name | Processor, Cervical Cytology Slide, Automated |
| Applicant | BD Diagnostic Systems |
| Date Received | 2003-03-24 |
| Decision Date | 2003-05-02 |
| PMA | P970018 |
| Supplement | S006 |
| Product Code | MKQ |
| 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 | BD Diagnostic Systems 4025 Stirrup Creek Drive suite 400 durham, NC 27703 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970018 | Original Filing | |
| S039 | 2021-09-24 | Real-time Process |
| S038 | 2021-02-19 | Real-time Process |
| S037 | 2021-01-21 | 30-day Notice |
| S036 | 2017-10-10 | Normal 180 Day Track No User Fee |
| S035 | 2017-07-17 | Normal 180 Day Track No User Fee |
| S034 | 2016-05-31 | 30-day Notice |
| S033 | 2016-05-27 | Real-time Process |
| S032 | 2015-03-26 | Normal 180 Day Track |
| S031 | 2015-01-22 | Normal 180 Day Track No User Fee |
| S030 | 2014-11-03 | Normal 180 Day Track |
| S029 | 2013-11-15 | 30-day Notice |
| S028 | 2013-10-31 | Normal 180 Day Track |
| S027 | 2013-09-30 | Special (immediate Track) |
| S026 | ||
| S025 | 2012-05-18 | 135 Review Track For 30-day Notice |
| S024 | 2011-08-24 | Special (immediate Track) |
| S023 | 2011-06-27 | Special (immediate Track) |
| S022 | ||
| S021 | 2010-04-05 | Real-time Process |
| S020 | 2010-02-18 | 30-day Notice |
| S019 | 2009-10-22 | Normal 180 Day Track |
| S018 | 2009-09-08 | Normal 180 Day Track No User Fee |
| S017 | 2009-06-11 | Normal 180 Day Track |
| S016 | 2009-06-09 | 30-day Notice |
| S015 | 2009-05-27 | Real-time Process |
| S014 | 2008-07-21 | Real-time Process |
| S013 | ||
| S012 | 2007-04-19 | Special (immediate Track) |
| S011 | ||
| S010 | 2005-09-01 | Real-time Process |
| S009 | 2005-01-10 | Real-time Process |
| S008 | ||
| S007 | 2003-12-01 | Normal 180 Day Track |
| S006 | 2003-03-24 | Normal 180 Day Track |
| S005 | 2002-08-26 | Normal 180 Day Track |
| S004 | 2002-07-02 | Normal 180 Day Track |
| S003 | 2001-10-26 | Real-time Process |
| S002 | 2000-12-01 | Normal 180 Day Track |
| S001 | 2000-08-08 | Real-time Process |