Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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Device | HER2 Dual ISH DNA Probe Cocktail |
Generic Name | Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer |
Applicant | Ventana Medical Systems, Inc. 1910 E. Innovation Park Drive Tucson, AZ 85755 |
PMA Number | P190031 |
Date Received | 11/29/2019 |
Decision Date | 07/28/2020 |
Product Code |
NYQ |
Docket Number | 20M-1724 |
Notice Date | 07/31/2020 |
Advisory Committee |
Pathology |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the VENTANA HER2 Dual ISH DNA Probe Cocktail assay. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S007 S008 S009 S010 |
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