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 | S010 |
Date Received | 05/07/2013 |
Decision Date | 05/29/2013 |
Product Code |
NYQ |
Advisory Committee |
Pathology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement QUALIFICATION OF A NEW SUPPLIER FOR A RAW MATERIAL THAT IS USED IN THE MANUFACTURE OF THE DETECTION KIT ASSOCIATED WITH THE INFORM HER-2 DUAL ISH DNA PROBE COCKTAIL. AS PART OF THIS CHANGE IN RAW MATERIAL, A CHANGE IN THE CELL MEDIA USED TO GROW THE ANTI-DNP ANTIBODY IS ALSO BEING IMPLEMENTED. |
|
|