Approval for the addition of the thermobrite automated slide heating plate supplied by an alternate vendor as an optional alternative of the hybrite automated slide heating plate instrument and to add instructions for use of said thermobrite to the current urovysion bladder cancer kit package insert.
| Device | UROVYSION BLADDER CANCER KIT |
| Classification Name | Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence |
| Generic Name | Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence |
| Applicant | ABBOTT MOLECULAR |
| Date Received | 2007-01-08 |
| Decision Date | 2007-02-06 |
| PMA | P030052 |
| Supplement | S002 |
| Product Code | NSD |
| Advisory Committee | Pathology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR 1300 E. Touhy Avenue des Plaines, IL 60018 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030052 | | Original Filing |
| S028 |
2022-02-18 |
30-day Notice |
| S027 |
2020-11-16 |
30-day Notice |
| S026 |
2019-07-31 |
30-day Notice |
| S025 |
2019-04-10 |
30-day Notice |
| S024 |
2018-08-10 |
30-day Notice |
| S023 |
2018-06-15 |
30-day Notice |
| S022 |
2018-02-16 |
30-day Notice |
| S021 |
2017-11-08 |
30-day Notice |
| S020 |
2016-11-22 |
Real-time Process |
| S019 |
2016-09-12 |
30-day Notice |
| S018 |
2016-09-02 |
30-day Notice |
| S017 |
2015-11-12 |
135 Review Track For 30-day Notice |
| S016 |
2014-07-24 |
30-day Notice |
| S015 |
2014-06-16 |
30-day Notice |
| S014 |
2013-11-25 |
30-day Notice |
| S013 |
2013-11-05 |
30-day Notice |
| S012 |
2013-08-29 |
Normal 180 Day Track No User Fee |
| S011 |
2013-01-16 |
30-day Notice |
| S010 |
2012-10-25 |
Special (immediate Track) |
| S009 |
2012-07-13 |
30-day Notice |
| S008 |
2011-06-23 |
30-day Notice |
| S007 |
2011-05-06 |
30-day Notice |
| S006 |
2011-04-28 |
Special (immediate Track) |
| S005 |
2011-03-18 |
30-day Notice |
| S004 |
2011-02-25 |
Special (immediate Track) |
| S003 |
2009-01-26 |
30-day Notice |
| S002 |
2007-01-08 |
Real-time Process |
| S001 |
2005-06-20 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices