|
Device | VENTANNA PATHWAY HER-2 (CLONE CB11) |
Generic Name | SYSTEM, TEST, HER-2/NEU, IHC |
Applicant | VENTANA MEDICAL SYSTEMS, INC. 1910 E. Innovation Park Dr. Tucson, AZ 85755 |
PMA Number | P990081 |
Supplement Number | S005 |
Date Received | 03/02/2007 |
Decision Date | 04/11/2007 |
Product Code |
MVC |
Advisory Committee |
Pathology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGE IN THE LABELING TO INCLUDE THE PATHWAY HER-2 4 IN 1 CONTROL SLIDES. |