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 | NMP22 BladderCheck Test |
| Generic Name | System, Test, Tumor Marker, For Detection Of Bladder Cancer |
| Applicant | Abbott Diagnostics Scarborough, Inc.10 Southgate Roadscarborough, ME 04074 PMA NumberP940035 Supplement NumberS017 Date Received02/08/2022 Decision Date07/12/2022 Product Code NAH Advisory Committee Immunology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No |
| Date Received | 2022-02-08 |
| Decision Date | 2022-07-12 |
| PMA | P940035 |
| Supplement | S017 |
| Product Code | NAH |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Diagnostics Scarborough, Inc. 10 Southgate Road scarborough, ME 04074 PMA NumberP940035 Supplement NumberS017 Date Received02/08/2022 Decision Date07/12/2022 Product Code NAH Advisory Committee Immunology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval To Manufacture Alere NMP22 BladderChek Test Under Abbott Diagnostics Scarborough, Inc.’s New Brand Name: NMP22 BladderChek Test |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940035 | Original Filing | |
| S017 | 2022-02-08 | Normal 180 Day Track No User Fee |
| S016 | 2021-05-27 | 30-day Notice |
| S015 | 2018-04-18 | 30-day Notice |
| S014 | 2017-01-30 | 30-day Notice |
| S013 | 2016-08-16 | 30-day Notice |
| S012 | 2016-04-06 | 30-day Notice |
| S011 | 2015-07-01 | 30-day Notice |
| S010 | 2013-07-10 | Special (immediate Track) |
| S009 | 2013-03-18 | 30-day Notice |
| S008 | 2010-11-22 | Normal 180 Day Track No User Fee |
| S007 | 2011-07-27 | Normal 180 Day Track No User Fee |
| S006 | 2011-05-11 | Normal 180 Day Track No User Fee |
| S005 | 2008-05-16 | Normal 180 Day Track No User Fee |
| S004 | 2008-03-27 | Normal 180 Day Track No User Fee |
| S003 | 2002-09-16 | Normal 180 Day Track |
| S002 | 1999-07-23 | Panel Track |
| S001 | 1996-12-16 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 10811877010637 | P940035 | 000 |
| 10811877010545 | P940035 | 000 |