Approval for the pathyvysion(tm) her-2 dna probe kit. The pathyvysion(tm) her-2 dna probe kit (pathyvysion kit) is designed to detect amplification ofthe her-2/neu gene via fluorescence in situ hybridization (fish) in formalin-fixed paraffin-embedded human breast cancer tissue speciments. Results from the pathvysion kit are intended for use as an adjuncto to existing clinical and pathologic information currently used as prognostic factors in state ii, node-positive breast cancer patients. The pathvysion kit is further indicated as an aid in predct disease-free and overall survival in patients with stage ii, node positive breast cancer treated with adjuvant cyclophosphamide, dosorubicin, and 5-fluorouracil (caf) chemotherapy.
| Device | PATHVYSION HER-2 DNA PROBE KIT |
| Classification Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
| Generic Name | System, Test, Her-2/neu, Nucleic Acid Or Serum |
| Applicant | ABBOTT MOLECULAR, INC. |
| Date Received | 1998-06-16 |
| Decision Date | 1998-12-11 |
| Notice Date | 1999-01-20 |
| PMA | P980024 |
| Supplement | S |
| Product Code | MVD |
| Docket Number | 99M-0034 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue des Plaines, IL 60018 |
Supplemental Filings
| 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 |
NIH GUDID Devices