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.
| Device | BD FocalPoint GS Imaging System |
| Generic Name | Reader, Cervical Cytology Slide, Automated |
| Applicant | BD DIAGNOSTICS4025 Stirrup Creek Drivesuite 400durham, NC 27703 PMA NumberP950009 Supplement NumberS026 Date Received06/15/2022 Decision Date07/11/2022 Product Code MNM Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-15 |
| Decision Date | 2022-07-11 |
| PMA | P950009 |
| Supplement | S026 |
| Product Code | MNM |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BD DIAGNOSTICS 4025 Stirrup Creek Drive suite 400 durham, NC 27703 PMA NumberP950009 Supplement NumberS026 Date Received06/15/2022 Decision Date07/11/2022 Product Code MNM Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Change Of Supplier For An Instrument Component |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P950009 | Original Filing | |
| S026 | 2022-06-15 | 30-day Notice |
| S025 | 2021-09-02 | Real-time Process |
| S024 | 2021-03-04 | 30-day Notice |
| S023 | 2019-11-19 | 30-day Notice |
| S022 | 2019-06-05 | Normal 180 Day Track |
| S021 | 2016-05-19 | 30-day Notice |
| S020 | 2016-03-07 | Normal 180 Day Track No User Fee |
| S019 | 2015-04-24 | Real-time Process |
| S018 | 2014-11-12 | Normal 180 Day Track |
| S017 | 2013-12-02 | Real-time Process |
| S016 | 2012-07-05 | Real-time Process |
| S015 | 2012-03-28 | Normal 180 Day Track |
| S014 | 2012-01-17 | Real-time Process |
| S013 | 2011-09-15 | Real-time Process |
| S012 | 2010-08-17 | Special (immediate Track) |
| S011 | 2009-12-10 | 30-day Notice |
| S010 | 2009-06-25 | Normal 180 Day Track No User Fee |
| S009 | 2009-03-26 | Real-time Process |
| S008 | 2007-10-02 | Panel Track |
| S007 | ||
| S006 | ||
| S005 | 2001-10-26 | Real-time Process |
| S004 | 1999-10-01 | Normal 180 Day Track |
| S003 | 1998-10-13 | Normal 180 Day Track |
| S002 | 1996-06-06 | Panel Track |
| S001 | 1995-11-06 | Special (immediate Track) |
| Device ID | PMA | Supp |
|---|---|---|
| 00382904901899 | P950009 | 008 |
| 00382904910877 | P950009 | 015 |
| 00382904910860 | P950009 | 015 |
| 00382904910853 | P950009 | 015 |
| 00382904910907 | P950009 | 015 |
| 00382904914646 | P950009 | 022 |