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.
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| Device | Vysis ALK Break Apart FISH Probe Kit |
| Classification Name | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement |
| Generic Name | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement |
| Applicant | ABBOTT MOLECULAR, INC. |
| Date Received | 2019-07-31 |
| Decision Date | 2019-08-26 |
| PMA | P110012 |
| Supplement | S019 |
| Product Code | OWE |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110012 | Original Filing | |
| S021 | 2020-11-16 | 30-day Notice |
| S020 | 2019-12-23 | Normal 180 Day Track |
| S019 | 2019-07-31 | 30-day Notice |
| S018 | 2019-04-10 | 30-day Notice |
| S017 | 2018-08-10 | 30-day Notice |
| S016 | 2018-06-15 | 30-day Notice |
| S015 | 2018-02-16 | 30-day Notice |
| S014 | 2017-11-08 | 30-day Notice |
| S013 | 2016-11-22 | Real-time Process |
| S012 | 2016-09-12 | 30-day Notice |
| S011 | 2016-09-02 | 30-day Notice |
| S010 | 2016-06-01 | 30-day Notice |
| S009 | 2014-10-01 | Normal 180 Day Track |
| S008 | 2014-07-24 | 30-day Notice |
| S007 | 2014-08-14 | Real-time Process |
| S006 | 2014-06-16 | 30-day Notice |
| S005 | 2013-11-05 | 30-day Notice |
| S004 | 2013-08-29 | Normal 180 Day Track No User Fee |
| S003 | 2013-03-20 | 30-day Notice |
| S002 | 2012-11-15 | 30-day Notice |
| S001 | 2011-12-19 | 135 Review Track For 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00884999025745 | P110012 | 001 |
| 00884999000735 | P110012 | 001 |
| 00884999042773 | P110012 | 009 |
| 00884999042728 | P110012 | 009 |
| 00884999038189 | P110012 | 009 |