|
Device | PATH VYSION HER-2 DNA PROBE KIT ASSAY |
Generic Name | SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM |
Applicant | ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P980024 |
Supplement Number | S007 |
Date Received | 06/14/2012 |
Decision Date | 12/20/2012 |
Product Code |
MVD |
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 MANUFACTURING CHANGE TO COMPONENTS OF THE PROBECHEK HER-2/NEU CUTOFF CONTROL SLIDES USED IN THE PATHVYSION HER-2 DNA PROBE KIT. THE CHANGE INCLUDED CREATION OF A NEW MASTER CELL BANK AND A NEW WORKING CELL BANK FROM SEED STOCK OF HS578T CELLS, USED IN THE MANUFACTURE OF THE PROBECHEK HER-2/NEU CUTOFFCONTROL SLIDES. |