|
Device | PROGENSA PCA3 ASSAY |
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 | S004 |
Date Received | 06/10/2015 |
Decision Date | 11/12/2015 |
Withdrawal Date
|
04/12/2023 |
Product Code |
OYM |
Advisory Committee |
Pathology |
Clinical Trials | NCT01024959
|
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 INTRODUCTION OF A NEW VIAL FILLER (THE CAPMATIC LINEAR BAMBINO FILLING SYSTEM) AT THE GCD1 MANUFACTURING FACILITY. |