PMA P100033S004

Device: PROGENSA PCA3 ASSAY
Applicant: Gen-Probe Incorporated
PMA number: P100033
Supplement: S004
Product code: OYM
Decision date: 2015-11-12
Classification: Prostrate Cancer Genes Nucleic Acid Amplification Test System
Generic name: Prostrate cancer genes nucleic acid amplification test system
Approval order statement: APPROVAL FOR THE INTRODUCTION OF A NEW VIAL FILLER (THE CAPMATIC LINEAR BAMBINO FILLING SYSTEM) AT THE GCD1 MANUFACTURING FACILITY.

Current openFDA PMA Record#

Device: PROGENSA PCA3 ASSAY
Applicant: Gen-Probe Incorporated
PMA number: P100033
Supplement: S004
Product code: OYM
Generic name: Prostrate cancer genes nucleic acid amplification test system
Decision date: 2015-11-12
Decision code: APPR
Date received: 2015-06-10
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE INTRODUCTION OF A NEW VIAL FILLER (THE CAPMATIC LINEAR BAMBINO FILLING SYSTEM) AT THE GCD1 MANUFACTURING FACILITY.