Approval to provide the definition for the pepsin activity of the vysis protease reagent in the urovysion 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 | 2011-02-25 |
| Decision Date | 2011-03-22 |
| PMA | P030052 |
| Supplement | S004 |
| Product Code | NSD |
| Advisory Committee | Pathology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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