Note: 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 | VENTANA HER2 Dual ISI-I 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 |
Supplement Number | S002 |
Date Received | 02/22/2021 |
Decision Date | 05/20/2021 |
Product Code |
NYQ |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the dispenser resin replacement used in the injection molding process for six (6) dispenser parts. |
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