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 | UroVysion Bladder Cancer Kit |
| Generic Name | Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence |
| Applicant | ABBOTT MOLECULAR1300 E. Touhy Avenuedes Plaines, IL 60018 PMA NumberP030052 Supplement NumberS028 Date Received02/18/2022 Decision Date03/18/2022 Product Code NSD Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-02-18 |
| Decision Date | 2022-03-18 |
| PMA | P030052 |
| Supplement | S028 |
| Product Code | NSD |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR 1300 E. Touhy Avenue des Plaines, IL 60018 PMA NumberP030052 Supplement NumberS028 Date Received02/18/2022 Decision Date03/18/2022 Product Code NSD Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement an Extension Of Expiration Dating Of Certain Assay Pretreatment Reagent Kit Components |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00884999002180 | P030052 | 001 |
| 00884999002142 | P030052 | 001 |