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 | PathVysion HER-2 DNA Probe Kit |
| Generic Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
| Applicant | ABBOTT MOLECULAR, INC.1300 East Touhy Avenuedes Plaines, IL 60018 PMA NumberP980024 Supplement NumberS022 Date Received02/18/2022 Decision Date03/18/2022 Product Code MVD 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 | P980024 |
| Supplement | S022 |
| Product Code | MVD |
| 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, INC. 1300 East Touhy Avenue des Plaines, IL 60018 PMA NumberP980024 Supplement NumberS022 Date Received02/18/2022 Decision Date03/18/2022 Product Code MVD 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 |
|---|---|---|
| P980024 | Original Filing | |
| S022 | 2022-02-18 | 30-day Notice |
| S021 | 2020-11-16 | 30-day Notice |
| S020 | 2019-04-10 | 30-day Notice |
| S019 | 2018-08-10 | 30-day Notice |
| S018 | 2018-06-15 | 30-day Notice |
| S017 | 2018-02-16 | 30-day Notice |
| S016 | 2017-11-08 | 30-day Notice |
| S015 | 2016-09-02 | 30-day Notice |
| S014 | 2016-06-01 | 30-day Notice |
| S013 | 2014-06-16 | 30-day Notice |
| S012 | 2013-11-25 | 30-day Notice |
| S011 | 2013-11-05 | 30-day Notice |
| S010 | 2013-01-16 | 30-day Notice |
| S009 | 2012-11-15 | 30-day Notice |
| S008 | 2012-06-21 | Special (immediate Track) |
| S007 | 2012-06-14 | 135 Review Track For 30-day Notice |
| S006 | 2011-10-17 | 135 Review Track For 30-day Notice |
| S005 | 2011-02-22 | 135 Review Track For 30-day Notice |
| S004 | 2010-12-22 | 30-day Notice |
| S003 | 2009-01-15 | 30-day Notice |
| S002 | 2005-06-20 | Normal 180 Day Track No User Fee |
| S001 | 2001-03-30 | Panel Track |
| Device ID | PMA | Supp |
|---|---|---|
| 00884999001763 | P980024 | 001 |
| 00884999001756 | P980024 | 001 |
| 00884999001732 | P980024 | 001 |