|
Device | PATHWAY ANTI-HER/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 | S030 |
Date Received | 06/16/2014 |
Decision Date | 02/19/2015 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF SANMINA BUILT NOZZLE PLATE ASSEMBLY IN THE MANUFACTURE OF BENCHMARK XT INSTRUMENT USED IN THE TESTS. |