|
Device | PATHWAY Anti-HER-2/neu (4B) Rabbit Monoclonal Primary Antibody |
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 | S045 |
Date Received | 01/28/2022 |
Decision Date | 06/10/2022 |
Product Code |
MVC |
Advisory Committee |
Pathology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of two new contract manufacturers as approved suppliers for component parts. |