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. |
|
Device | INFORM HER-2 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 Dr. Tucson, AZ 85755 |
PMA Number | P100027 |
Supplement Number | S004 |
Date Received | 09/26/2012 |
Decision Date | 11/21/2012 |
Withdrawal Date
|
05/07/2024 |
Product Code |
NYQ |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE CHANGE OF THE TWO LITER (2L) BOTTLES FOR EACH OF THE AQUEOUS-BASED REAGENTS FROM FLUORINATED TO NON-FLUORINATED BOTTLES. |
|
|