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 modification to the surepath slide preparation method which will be marketed under the trade name prepstain system and is indicated for use as a liquid-based thin layer cell preparation process. The prestain system produces surepath slides that are intended as replacements for conventional gynecologic pap smears. Surepath slides are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other cytologic categories as defined by the bethesda system for reporting cervical/vaginal cytologic diagnoses.
| Device | PREPSTAIN SYSTEM |
| Generic Name | Processor, Cervical Cytology Slide, Automated |
| Applicant | BD Diagnostic Systems |
| Date Received | 2005-01-10 |
| Decision Date | 2005-02-11 |
| PMA | P970018 |
| Supplement | S009 |
| Product Code | MKQ |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |