|
Device | Progensa PCA3 Assay |
Classification Name | prostrate cancer genes nucleic acid amplification test system |
Generic Name | prostrate cancer genes nucleic acid amplification test system |
Applicant |
GEN-PROBE INCORPORATED |
10210 genetic center drive |
san diego, CA 92121 |
|
PMA Number | P100033 |
Supplement Number | S008 |
Date Received | 02/08/2018 |
Decision Date | 03/07/2018 |
Product Code | |
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
Change of subcomponent manufacturing location. |